EUDAMED update: Oct 30, 2025

bitop AG

DE-MF-000006543

Active215 devices

Address: Stockumer Str., 28 58453 Witten
Role: Manufacturer
Date of registration: Jun 1, 2021
Country: Germany

bitop AG is a medical device manufacturer registered in EUDAMED. The company has 215 devices on the EU market across 27 countries. It holds 2 valid CE certificates. Headquartered in Witten, Germany. Explore the regulatory profile, devices and certificates on MD Atlas.

About bitop AG

: DE-MF-000006543
Role: Manufacturer
Country: Germany
Organization name: bitop AG
EU VAT number: DE 243 855 091
Trade register: HRB 8147
Date of registration: Jun 1, 2021

Contact details for bitop AG

Email: info@bitop.de
Address: 28, STOCKUMER STR. 58453 WITTEN GERMANY

Competent authority

Name: DE/CA18 - Bezirksregierung Arnsberg

Phone: +492931-82-0
Email: poststelle@bra.nrw.de

Officers and regulatory representatives of bitop AG

TEUBNER-MAYLE Natascha Caroline
Art.15 (3) a & e: The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released and in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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SCHWARTZKOPFF Benjamin
Art.15 (3) b, c & d: The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. The post-market surveillance obligations are complied with in accordance with Article 10(10) and the reporting obligations referred to in Articles 87 to 91 are fulfilled.
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BOU MALHAB Majed
Art. 15 (3) b: The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Hidden
VAGHEF Arman
Art. 15 (3) b: The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Hidden
KHOSHNYAT Ramtin
Art. 15 (3) b: The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
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Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
0,6% medEctoin® Protect Lozenges Cherry	0,6% medEctoin® Protect Lozenges Cherry	`80006`	`D-DE-MF-000006543-80006U3`	1	On the market
0,6% medEctoin® Protect Lozenges Honey Lemon	0,6% medEctoin® Protect Lozenges Honey Lemon	`80005`	`D-DE-MF-000006543-80005TZ`	1	On the market
0.5% medEctoin® Sicca Eye Drops + HA 0.2%	0.5% medEctoin® Sicca Eye Drops + HA 0.2%	`38166`	`D-DE-MF-000006543-38166UT`	1	On the market
0.5% medEctoin® Sicca Nasal Spray	0.5% medEctoin® Sicca Nasal Spray	`38117`	`D-DE-MF-000006543-38117UE`	1	On the market
0.5% medEctoin®Sicca Eye Drops + HA 0.2%	0.5% medEctoin®Sicca Eye Drops + HA 0.2%	`80091`	`D-DE-MF-000006543-80091UL`	1	On the market
0.6% medEctoin Lozenges Cherry	0.6% medEctoin Lozenges Cherry	`38112`	`D-DE-MF-000006543-38112U4`	1	On the market
0.6% medEctoin Lozenges Honey Lemon	0.6% medEctoin Lozenges Honey Lemon	`38111`	`D-DE-MF-000006543-38111U2`	1	On the market
1.3% medEctoin® Inhalation Solution	1.3% medEctoin® Inhalation Solution	`38108`	`D-DE-MF-000006543-38108UD`	1	On the market
1% medEctoin® Mouth and Throat Spray Salvia	1% medEctoin® Mouth and Throat Spray Salvia	`39908/ERS04`	`04260265221671`	1	On the market
1% medEctoin® Soft Lozenges	1% medEctoin® Soft Lozenges	`38143`	`D-DE-MF-000006543-38143UF`	1	On the market
2% medEctoin Rhinitis Nasal Spray	2% medEctoin Rhinitis Nasal Spray	`38109`	`D-DE-MF-000006543-38109UF`	1	On the market
2% medEctoin® Allergy Eye Drops	2% medEctoin® Allergy Eye Drops	`38124`	`D-DE-MF-000006543-38124UB`	1	On the market
2% medEctoin® Allergy Eye Drops	2% medEctoin® Allergy Eye Drops	`38113`	`D-DE-MF-000006543-38113U6`	1	On the market
2% medEctoin® Allergy Nasal Spray	2% medEctoin® Allergy Nasal Spray	`38116`	`D-DE-MF-000006543-38116UC`	1	On the market
2% medEctoin® Allergy Nasal Spray Forte	2% medEctoin® Allergy Nasal Spray Forte	`38107`	`D-DE-MF-000006543-38107UB`	1	On the market
2% medEctoin® Eye Gel	2% medEctoin® Eye Gel	`38115`	`D-DE-MF-000006543-38115UA`	1	On the market
2% medEctoin® Inflammation Reducing Eye Drops	2% medEctoin® Inflammation Reducing Eye Drops	`38114`	`D-DE-MF-000006543-38114U8`	1	On the market
2% medEctoin® Inflammation Reducing Eye Drops	2% medEctoin® Inflammation Reducing Eye Drops	`38125`	`D-DE-MF-000006543-38125UD`	1	On the market
2% medEctoin® Inflammation Reducing Eye Drops	2% medEctoin® Inflammation Reducing Eye Drops	`80002`	`D-DE-MF-000006543-80002TT`	1	On the market
5% medEctoin® Psoriasis Akut Creme	5% medEctoin® Psoriasis Akut Creme	`38130`	`D-DE-MF-000006543-38130U6`	1	On the market
A.Vogel Kapljice za oči pri vnetju	A.Vogel Kapljice za oči pri vnetju	`38096`	`D-DE-MF-000006543-38096UX`	1	On the market
A.Vogel neusspray bijholteontsteking	A.Vogel neusspray bijholteontsteking	`38100`	`04260265220735`	1	On the market
A.Vogel Oogdruppels ontstoken ogen	A.Vogel Oogdruppels ontstoken ogen	`33026`	`D-DE-MF-000006543-33026T7`	1	On the market
A.Vogel Gouttes pour les yeux inflammation des yeux	A.Vogel Gouttes pour les yeux inflammation des yeux	`33028`	`D-DE-MF-000006543-33028TB`	1	On the market
A.Vogel Gel pour les yeux hydratation intense	A.Vogel Gel pour les yeux hydratation intense	`33029`	`D-DE-MF-000006543-33029TD`	1	On the market

Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
0,6% medEctoin® Protect Lozenges Cherry	0,6% medEctoin® Protect Lozenges Cherry	`80006`	`D-DE-MF-000006543-80006U3`	1	On the market
0,6% medEctoin® Protect Lozenges Honey Lemon	0,6% medEctoin® Protect Lozenges Honey Lemon	`80005`	`D-DE-MF-000006543-80005TZ`	1	On the market
0.5% medEctoin® Sicca Eye Drops + HA 0.2%	0.5% medEctoin® Sicca Eye Drops + HA 0.2%	`38166`	`D-DE-MF-000006543-38166UT`	1	On the market
0.5% medEctoin® Sicca Nasal Spray	0.5% medEctoin® Sicca Nasal Spray	`38117`	`D-DE-MF-000006543-38117UE`	1	On the market
0.5% medEctoin®Sicca Eye Drops + HA 0.2%	0.5% medEctoin®Sicca Eye Drops + HA 0.2%	`80091`	`D-DE-MF-000006543-80091UL`	1	On the market
0.6% medEctoin Lozenges Cherry	0.6% medEctoin Lozenges Cherry	`38112`	`D-DE-MF-000006543-38112U4`	1	On the market
0.6% medEctoin Lozenges Honey Lemon	0.6% medEctoin Lozenges Honey Lemon	`38111`	`D-DE-MF-000006543-38111U2`	1	On the market
1.3% medEctoin® Inhalation Solution	1.3% medEctoin® Inhalation Solution	`38108`	`D-DE-MF-000006543-38108UD`	1	On the market
1% medEctoin® Mouth and Throat Spray Salvia	1% medEctoin® Mouth and Throat Spray Salvia	`39908/ERS04`	`04260265221671`	1	On the market
1% medEctoin® Soft Lozenges	1% medEctoin® Soft Lozenges	`38143`	`D-DE-MF-000006543-38143UF`	1	On the market
2% medEctoin Rhinitis Nasal Spray	2% medEctoin Rhinitis Nasal Spray	`38109`	`D-DE-MF-000006543-38109UF`	1	On the market
2% medEctoin® Allergy Eye Drops	2% medEctoin® Allergy Eye Drops	`38124`	`D-DE-MF-000006543-38124UB`	1	On the market
2% medEctoin® Allergy Eye Drops	2% medEctoin® Allergy Eye Drops	`38113`	`D-DE-MF-000006543-38113U6`	1	On the market
2% medEctoin® Allergy Nasal Spray	2% medEctoin® Allergy Nasal Spray	`38116`	`D-DE-MF-000006543-38116UC`	1	On the market
2% medEctoin® Allergy Nasal Spray Forte	2% medEctoin® Allergy Nasal Spray Forte	`38107`	`D-DE-MF-000006543-38107UB`	1	On the market
2% medEctoin® Eye Gel	2% medEctoin® Eye Gel	`38115`	`D-DE-MF-000006543-38115UA`	1	On the market
2% medEctoin® Inflammation Reducing Eye Drops	2% medEctoin® Inflammation Reducing Eye Drops	`38114`	`D-DE-MF-000006543-38114U8`	1	On the market
2% medEctoin® Inflammation Reducing Eye Drops	2% medEctoin® Inflammation Reducing Eye Drops	`38125`	`D-DE-MF-000006543-38125UD`	1	On the market
2% medEctoin® Inflammation Reducing Eye Drops	2% medEctoin® Inflammation Reducing Eye Drops	`80002`	`D-DE-MF-000006543-80002TT`	1	On the market
5% medEctoin® Psoriasis Akut Creme	5% medEctoin® Psoriasis Akut Creme	`38130`	`D-DE-MF-000006543-38130U6`	1	On the market
A.Vogel Kapljice za oči pri vnetju	A.Vogel Kapljice za oči pri vnetju	`38096`	`D-DE-MF-000006543-38096UX`	1	On the market
A.Vogel neusspray bijholteontsteking	A.Vogel neusspray bijholteontsteking	`38100`	`04260265220735`	1	On the market
A.Vogel Oogdruppels ontstoken ogen	A.Vogel Oogdruppels ontstoken ogen	`33026`	`D-DE-MF-000006543-33026T7`	1	On the market
A.Vogel Gouttes pour les yeux inflammation des yeux	A.Vogel Gouttes pour les yeux inflammation des yeux	`33028`	`D-DE-MF-000006543-33028TB`	1	On the market
A.Vogel Gel pour les yeux hydratation intense	A.Vogel Gel pour les yeux hydratation intense	`33029`	`D-DE-MF-000006543-33029TD`	1	On the market

bitop AG

About bitop AG

Contact details for bitop AG

Competent authority

Officers and regulatory representatives of bitop AG

Related searches

About bitop AG

Contact details for bitop AG

Competent authority

Officers and regulatory representatives of bitop AG

Approved members

Statistics for bitop AG

Certificate health for bitop AG

Issuing notified bodies

Related documents

Devices by risk class

Device catalog for bitop AG

Device families (Basic UDI-DI) of bitop AG

Market presence of bitop AG

Related searches

Certificate health for bitop AG

Statistics for bitop AG

Market presence of bitop AG

Devices by risk class

Issuing notified bodies

Approved members

Related documents

Device families (Basic UDI-DI) of bitop AG

Device catalog for bitop AG