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Safe Block
EUDAMEDClass IIa (EU MDR)
Ref 9621Model type 820Ref 7017Ref 9601Ref 7015Ref 7016
Identity
- Trade Name
- Safe Block EUDAMED
- Device Name
- Safety pen needle EUDAMED
- Model / Reference
- type 820 EUDAMED9621 EUDAMED7017 EUDAMED9601 EUDAMED7015 EUDAMED7016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999600235 EUDAMED05903999603991 EUDAMED05903999600259 EUDAMED05903999603977 EUDAMED05903999603984 EUDAMED
- Basic UDI-DI
- 590799609820MU EUDAMEDB-05903999603991 EUDAMEDB-05903999603977 EUDAMEDB-05903999603984 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Safe Block by Htl Strefa S A — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 590799609820MU | Class IIa | Active |
| 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 (5)
- EUDAMED 632afc63-cb65-4815-ae7d-8c247b320d25 61 fields · synced Jul 27, 2026
- EUDAMED 5d383a3b-6f9e-4a92-bb3c-5941abe4c776 61 fields · synced May 16, 2026
- EUDAMED 33823fc5-97d2-4d2e-be6b-fca1353cff9f 61 fields · synced May 17, 2026
- EUDAMED adb0ea94-8309-42ae-a26b-c12f4da0108b 61 fields · synced May 18, 2026
- EUDAMED e6e5ed3e-6692-4fb6-a200-548b5d5b5a07 61 fields · synced May 19, 2026