Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

38108 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Dec 2, 2025

38108

B-DE-MF-000006543-38108UD

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-38108UD
Reference / catalog number: 38108

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: bitop AG
SRN: DE-MF-000006543
Manufacturer status: Active

Related devices

0,6% medEctoin® Protect Lozenges CherryB-DE-MF-000006543-80006U3On the market 0,6% medEctoin® Protect Lozenges Honey LemonB-DE-MF-000006543-80005TZOn the market 0.5% medEctoin® Sicca Eye Drops + HA 0.2%B-DE-MF-000006543-38166UTOn the market 1% medEctoin® Mouth and Throat Spray Salvia426026522BITOP-ERS-C168On the market 1% medEctoin® Soft LozengesB-DE-MF-000006543-38143UFOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Warnings and precautions • The Product should not be used during persisting traumas, for example after surgery of the respiratory system. • The Product should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients. • If side effects occur, the use of the Product must be discontinued immediately. • After usage of one single dose unit, the remaining liquid must be discarded, it is not intended for later usage. • The Product is filled in small plastic parts that could be swallowed by small children. To avoid danger of suffocation, the Product should be kept out of reach of children. • Do not use damaged or punctured single dose units. • Do not inhale too quickly.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-38108UD
Basic UDI-DI: B-DE-MF-000006543-38108UD
Reference / catalog number: 38108
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R060203INHALATION THERAPY HUMIDIFICATION LIQUIDS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification