Identity
- Trade Name
- Film Cutting Machine EUDAMED
- Device Name
- Film Cutting Machine EUDAMED
- Model / Reference
- FCM-1、FCM-2、FCM-3 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141982215 EUDAMED06975141982239 EUDAMED06975141982222 EUDAMED
- Basic UDI-DI
- 697514198AS147FH EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMEDEUDAMED
Film Cutting Machine by Hangzhou Allsheng Instruments Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697514198AS147FH | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Allsheng Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000020502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 1df27d25-7ca2-4360-802e-b0deb450a2d3 61 fields · synced Oct 6, 2026
- EUDAMED 0dc8b2d1-9537-4570-bd2f-d5d219f63192 61 fields · synced May 19, 2026
- EUDAMED 6c95ab2e-44fc-4038-aa6b-816d61770bc5 61 fields · synced May 19, 2026