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Certeza
EUDAMEDClass IIa (EU MDR)
Ref LT-28 Soft 28G 01-0128Ref 01-0128 Soft 28G
Identity
- Trade Name
- CERTEZA EUDAMED
- Device Name
- Disposable Blood Lancets EUDAMED
- Model / Reference
- LT-28 Soft 28G 01-0128 EUDAMED01-0128 Soft 28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630132190 EUDAMED16945630131827 EUDAMED
- Basic UDI-DI
- 6945630101B9 EUDAMED
- Unit of Use DI
- 06945630132193 EUDAMED06945630131820 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
Certeza by Sterilance Medical (Suzhou) Inc. — 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 | 6945630101B9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7e6a1b76-1cfe-4722-b946-1bf939ad1bed 61 fields · synced Sep 17, 2026
- EUDAMED 1e32c68c-b20f-453e-bd55-f2569e0db7f9 61 fields · synced May 17, 2026