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diamet mySafety
EUDAMEDClass IIa (EU MDR)
Ref 8168Model type 820Ref 8445Ref 8169
Identity
- Trade Name
- diamet mySafety EUDAMED
- Device Name
- Safety pen needle EUDAMED
- Model / Reference
- type 820 EUDAMED8168 EUDAMED8445 EUDAMED8169 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996091300 EUDAMED05903999603854 EUDAMED05907996091317 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
diamet mySafety 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 9a4070fd-6f51-4996-8878-430b31426195 61 fields · synced Jul 26, 2026
- EUDAMED 707eba4d-8623-432d-add2-89567a053b08 61 fields · synced May 17, 2026
- EUDAMED bc4d47b6-a4cd-4638-b68c-12f76c183519 61 fields · synced May 17, 2026