Identity
- Trade Name
- AutoProtect EUDAMED
- Device Name
- Safety pen needle EUDAMED
- Model / Reference
- type 820 EUDAMED9624 EUDAMED9625 EUDAMED9340 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999607357 EUDAMED05903999607364 EUDAMED05903999608019 EUDAMED
- Basic UDI-DI
- 590799609820MU EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
AutoProtect by Htl Strefa S A — Class IIa — 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 | 590799609820MU | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (3)
- EUDAMED e0e57c19-a419-4371-9c65-507c0b7397d8 61 fields · synced Aug 3, 2026
- EUDAMED cbf2b20f-eafa-4bae-ab4c-bb83132f5226 61 fields · synced May 18, 2026
- EUDAMED 3b321d54-2c96-4b6c-b3bc-20d159785631 61 fields · synced May 19, 2026