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

38133 — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jul 17, 2025

38133

B-38133GT

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-38133GT
Reference / catalog number: 38133

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 38108B-DE-MF-000006543-38108UDOn the market 1% medEctoin® Mouth and Throat Spray Salvia426026522BITOP-ERS-C168On 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
Should not be used during persisting traumas, e. g. after surgery or injuries of the mouth. Should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the lozenges. If allergic reactions occur, the use of the product must be discontinued immediately. Children younger than 6 years should not use the product due to danger of suffocation. Do not use the lozenges while lying down, e.g. at bedtime, due to the risk of choking. Do not use lozenges from damaged or punctured blisters. Should be kept out of reach of children.

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-38133GT
Basic UDI-DI: B-38133GT
Reference / catalog number: 38133
Issuing entity: EUDAMED

Classification

Risk category: Class I
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: 16 Lozenges with a weigth of 2.3 gram per Lozenge

EMDN nomenclature code(s)

Q0399ENT DEVICES - OTHER

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