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Faustum
EUDAMEDClass IIa (EU MDR)
Ref Standard Ⅰ SS 24#Ref Standard Ⅰ SS 12#Ref Standard Ⅰ SS 23#Ref Standard Ⅰ SS 15#Ref Standard Ⅰ SS 21#Ref Standard Ⅰ SS 22#
Identity
- Trade Name
- Faustum EUDAMED
- Device Name
- Disposable Scalpels EUDAMED
- Model / Reference
- Standard Ⅰ SS 24# EUDAMEDStandard Ⅰ SS 12# EUDAMEDStandard Ⅰ SS 23# EUDAMEDStandard Ⅰ SS 15# EUDAMEDStandard Ⅰ SS 21# EUDAMEDStandard Ⅰ SS 22# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630141505 EUDAMED16945630141444 EUDAMED16945630141499 EUDAMED16945630141451 EUDAMED16945630141475 EUDAMED16945630141482 EUDAMED
- Basic UDI-DI
- 6945630107BM EUDAMED
- Unit of Use DI
- 06945630141508 EUDAMED06945630141447 EUDAMED06945630141492 EUDAMED06945630141454 EUDAMED06945630141478 EUDAMED06945630141485 EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Faustum 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 | 6945630107BM | 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 (6)
- EUDAMED 1e57e6da-667c-41a3-9351-493b5c1f8e14 61 fields · synced Jul 30, 2026
- EUDAMED 0253206a-2fcd-4e36-864c-0b109686c2d8 61 fields · synced May 16, 2026
- EUDAMED 4d73638c-1242-465c-afe8-f1a5ebced7b2 61 fields · synced May 17, 2026
- EUDAMED 55e13dd4-e309-449d-9519-29a82de5e857 61 fields · synced May 17, 2026
- EUDAMED 8cfbf18f-b17f-4200-8427-b0c8793969d5 61 fields · synced May 18, 2026
- EUDAMED f84d910a-9625-4de7-8823-2b47b454865e 61 fields · synced May 18, 2026