Identity
- Trade Name
- BEROFINE SAFETY EUDAMED
- Device Name
- BEROFINE hypodermic needle EUDAMED
- Model / Reference
- 911556EB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 54032731911554 EUDAMED
- Basic UDI-DI
- 4032731G10-01IIaEL EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Berofine Safety by Beromed GmbH Hospital Products — Class IIa — CE/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 | 4032731G10-01IIaEL | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beromed GmbH Hospital Products
- EUDAMED SRN
- DE-MF-000007458
Sources (1)
- EUDAMED f9d3be36-bf3d-47f7-bb6d-3d99c9411e57 61 fields · synced Oct 6, 2026