Identity
- Device Name
- Atroflex EUDAMED
- Model / Reference
- FFP060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555921900577 EUDAMED
- Basic UDI-DI
- 955592190FFP060FN EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Atroflex by Farmasia Sdn Bhd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955592190FFP060FN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Farmasia Sdn Bhd
- EUDAMED SRN
- MY-MF-000044087
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (1)
- EUDAMED d2e34789-02be-4e8a-b411-561c6cf03cd4 61 fields · synced Jul 15, 2026