Identity
- Device Name
- Sterile Safety Lancets EUDAMED
- Model / Reference
- 5001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923376550013 EUDAMED
- Basic UDI-DI
- B-06923376550013 EUDAMED69233765SSL0001UJ EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Sterile Safety Lancets by Suzhou Zhenwu Medical Co., Ltd. — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223208 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06923376550013 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06923376550013 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Zhenwu Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000038352
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (3)
- EUDAMED 39460f97-22b7-42ba-879d-91a049ee44c8 61 fields · synced Oct 6, 2026
- EUDAMED d30ae8a1-957a-4341-b5cc-9434c83c4836 61 fields · synced May 17, 2026
- FDA 510(k) K223208 1 fields · synced May 18, 2026