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Solofix Safety
EUDAMEDClass IIa (EU MDR)
Ref 7133Model Type 553-556Ref 7131Model type 553-556
Identity
- Trade Name
- Solofix Safety EUDAMEDSolofix® Safety EUDAMED
- Device Name
- Safety lancet EUDAMED
- Model / Reference
- Type 553-556 EUDAMED7133 EUDAMED7131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999603298 EUDAMED05903999603304 EUDAMED
- Basic UDI-DI
- 5907996095535563D EUDAMEDB-05903999603298 EUDAMEDB-05903999603304 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
Solofix Safety by Htl Strefa S A — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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 | 5907996095535563D | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5907996095535563D | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (4)
- EUDAMED 78be7bae-7439-4301-9dca-e8174932c5ce 61 fields · synced Sep 17, 2026
- EUDAMED 5932e251-1b19-4be5-8516-a1cbaff16853 61 fields · synced May 19, 2026
- EUDAMED 92df8006-395e-4739-906d-e0a6812db7e5 61 fields · synced Jul 15, 2026
- EUDAMED 1752b99b-5b68-4765-8d31-87b27076ff08 61 fields · synced Jul 16, 2026