Identity
- Trade Name
- Haemofine EUDAMED
- Device Name
- pen needle EUDAMED
- Model / Reference
- type 810 EUDAMED8004 EUDAMED8001 EUDAMED8002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907506237792 EUDAMED05907506237761 EUDAMED05907506237778 EUDAMED
- Basic UDI-DI
- B-05907506237792 EUDAMEDB-05907506237761 EUDAMEDB-05907506237778 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Haemofine by Htl Strefa S A — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05907506237792 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (3)
- EUDAMED 99ec5550-a5ac-4fbf-8294-b10aa61cc74c 61 fields · synced Jul 30, 2026
- EUDAMED 7aed10a8-94e1-4ae8-9770-39158c1fc562 61 fields · synced May 16, 2026
- EUDAMED e241ab42-18ed-467b-b2dd-20b0fb559a00 61 fields · synced May 17, 2026