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"index Asurity STERiLANCE "
EUDAMEDClass IIa (EU MDR)
Ref "Asurity SS #15 22-0315"
Identity
- Trade Name
- "index Asurity STERiLANCE " EUDAMED
- Device Name
- Disposable Scalpels EUDAMED
- Model / Reference
- "Asurity SS #15 22-0315" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630143547 EUDAMED
- Basic UDI-DI
- 6945630122BH EUDAMED
- Unit of Use DI
- 06945630143540 EUDAMED
- EMDN Code
- V010101 SCALPELS WITH 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
"index Asurity STERiLANCE " 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 | 6945630122BH | 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 (1)
- EUDAMED 9c490042-e75e-44f9-a176-90e828043dd8 61 fields · synced Jun 19, 2026