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

Hydralin ConfortVaginal — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 19, 2026

Hydralin ConfortVaginal

B-DE-MF-000006543-38069UU

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-38069UU
Reference / catalog number: 38069

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

Critical warnings

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

CW999
If allergic reactions occur, discontinue use immediately. Do not use damaged products. Before each application, the applicator must be carefully checked for its integrity. Do not use the applicator, if it is damaged (e.g. has visible cracks or chips) or its plunger is loosened and disassembles from the tube easily. To ensure safe hygiene, this product should only be used by one person. Do not use for more than 3 months after opening. Keep out of reach of children. If conditions persist or worsen, or if signs of infection (as a vaginal discharge of an unusual colour/consistency/odour) occur, contact your healthcare provider or pharmacist. The product is neither spermicide, nor supporting conception. The product does not protect against sexually transmitted diseases. The product has no contraceptive action and cannot be used to prevent pregnancy. Product should not be used in case of hypersensitivity to Ectoin®, Propylene Glycol or any of the other ingredients of the gel. Do not use in case of traumas or surgeries in the vaginal area. Do not use during vulvovaginal infections. Do not use the intravaginal applicator during pregnancy.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: Hydralin ConfortVaginal
UDI-DI code: D-DE-MF-000006543-38069UU
Basic UDI-DI: B-DE-MF-000006543-38069UU
Reference / catalog number: 38069
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U0899GYNAECOLOGICAL 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

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.