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Single-Let
EUDAMEDClass IIa (EU MDR)
Ref 9035Model type 430Ref 9046Model type 520Ref 9044Ref 9041
Identity
- Trade Name
- Single-Let EUDAMEDSingle-let next EUDAMED
- Device Name
- safety lancet EUDAMED
- Model / Reference
- type 430 EUDAMED9035 EUDAMEDtype 520 EUDAMED9046 EUDAMED9044 EUDAMED9041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016003585104 EUDAMED05903999605490 EUDAMED05903999605476 EUDAMEDD-9041BC EUDAMED
- Basic UDI-DI
- B-05016003585104 EUDAMEDB-05903999605490 EUDAMEDB-05903999605476 EUDAMEDB-9041BC EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDDenmark EUDAMEDGermany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
Single-Let by Htl Strefa S A — Class IIa — MDD — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05016003585104 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (4)
- EUDAMED f789cc69-91b9-4a51-9fab-1e7b550bfa22 61 fields · synced Jul 19, 2026
- EUDAMED 82e4b3ef-0364-4a7f-b903-b964d60871e2 61 fields · synced May 19, 2026
- EUDAMED c71f2601-137a-496c-859b-dbeabc85f7da 61 fields · synced May 19, 2026
- EUDAMED bcbab98a-9944-4da8-88df-96e9d9a7c753 61 fields · synced Jul 9, 2026