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Bioginefarma
EUDAMEDClass IIa (EU MDR)
Ref Impress Pro 28G 1.8mmRef 01-0130 Soft 30G
Identity
- Trade Name
- Bioginefarma EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMEDDisposable Blood Lancets EUDAMED
- Model / Reference
- Impress Pro 28G 1.8mm EUDAMED01-0130 Soft 30G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630140522 EUDAMED16945630135412 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED6945630101B9 EUDAMED
- Unit of Use DI
- 06945630135415 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Bioginefarma by Sterilance Medical (Suzhou) Inc. — Class IIa — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6945630105BH | 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 e628056e-7c54-4d33-a3b6-b99f0ad33922 61 fields · synced Jul 24, 2026
- EUDAMED 50dc7a11-fd08-4d5e-8780-d950f85290d4 61 fields · synced May 19, 2026