Identity
- Trade Name
- BEROFINE SAFETY EUDAMED
- Device Name
- BEROFINE hypodermic needle EUDAMED
- Model / Reference
- 911679EB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 54032731911677 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
Category: Hypodermic needle, single-use
Berofine Safety by Beromed GmbH Hospital Products — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Beromed GmbH Hospital Products
- EUDAMED SRN
- DE-MF-000007458
Sources (1)
- EUDAMED 1540f0b5-90fb-4dc8-9354-6059edb73549 61 fields · synced Jun 19, 2026