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M&B Health
EUDAMEDClass IIa (EU MDR)
Ref 05-193018 Impress Pro 30G 1.8mmRef 05-192818 Impress Pro 28G 1.8mm
Identity
- Trade Name
- M&B Health EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMED
- Model / Reference
- 05-193018 Impress Pro 30G 1.8mm EUDAMED05-192818 Impress Pro 28G 1.8mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630134101 EUDAMED16945630134118 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED
- Unit of Use DI
- 06945630134104 EUDAMED06945630134111 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
M&B Health 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 8931f6e3-7e58-494f-9708-3fa400e12a2c 61 fields · synced Jul 24, 2026
- EUDAMED 635053e7-e091-4276-820a-b9b7e39d5653 61 fields · synced May 17, 2026