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Vivent
EUDAMEDClass IIa (EU MDR)
Ref 10-0125 Standard CS 25YRef 10-0122 Standard CS 22YRef 10-0112 Standard CS 12YRef 10-0118 Standard CS 18YRef 01-0130 Soft 30GRef 10-0110 Standard CS 10YRef 10-0115 Standard CS 15YRef 10-0123 Standard CS 23YRef 10-0121 Standard CS 21Y
Identity
- Trade Name
- VIVENT EUDAMED
- Device Name
- Disposable Surgical Blades EUDAMEDDisposable Blood Lancets EUDAMED
- Model / Reference
- 10-0125 Standard CS 25Y EUDAMED10-0122 Standard CS 22Y EUDAMED10-0112 Standard CS 12Y EUDAMED10-0118 Standard CS 18Y EUDAMED01-0130 Soft 30G EUDAMED10-0110 Standard CS 10Y EUDAMED10-0115 Standard CS 15Y EUDAMED10-0123 Standard CS 23Y EUDAMED10-0121 Standard CS 21Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630130806 EUDAMED16945630130776 EUDAMED16945630130721 EUDAMED16945630130745 EUDAMED16945630130813 EUDAMED16945630130707 EUDAMED16945630130738 EUDAMED16945630130783 EUDAMED16945630130769 EUDAMED
- Basic UDI-DI
- 6945630110BA EUDAMED6945630101B9 EUDAMED
- Unit of Use DI
- 06945630130809 EUDAMED06945630130779 EUDAMED06945630130724 EUDAMED06945630130748 EUDAMED06945630130816 EUDAMED06945630130700 EUDAMED06945630130731 EUDAMED06945630130786 EUDAMED06945630130762 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMEDV010402 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
Vivent 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 | 6945630110BA | 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 (9)
- EUDAMED 427d7099-6eb0-4d98-a949-d8b0936319eb 61 fields · synced Jul 28, 2026
- EUDAMED e5d3449e-fa84-4de5-b5f8-4437d908227c 61 fields · synced May 11, 2026
- EUDAMED 5c0d2a4f-ed0a-481c-bf59-8312d5c0b5b9 61 fields · synced May 16, 2026
- EUDAMED afb81fa4-7e10-409a-b9d0-781e2bb9c1b6 61 fields · synced May 17, 2026
- EUDAMED aeadb0a1-36e1-4bc3-8184-ba14b5f60525 61 fields · synced May 17, 2026
- EUDAMED c457ef04-dacf-4b38-9443-7acde873efb6 61 fields · synced May 17, 2026
- EUDAMED 250fbb38-1ed1-4c4f-a53c-49be28028814 61 fields · synced May 18, 2026
- EUDAMED bb2efdb2-d5af-4779-b17d-7f4313df22dd 61 fields · synced May 18, 2026
- EUDAMED 2f96b9a9-eb5d-4012-9e16-ff65a8db6dc7 61 fields · synced May 18, 2026