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Bio-Fragment Analyzing System
EUDAMEDClass A (EU MDR)
Ref -Model GeneCE-100、GeneCE-Mini
Identity
- Trade Name
- Bio-Fragment Analyzing System EUDAMED
- Device Name
- Bio-Fragment Analyzing System EUDAMED
- Model / Reference
- GeneCE-100、GeneCE-Mini EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141982338 EUDAMED06975141982116 EUDAMED
- Basic UDI-DI
- 697514198AS246FL 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
No
EUDAMEDEUDAMED
Bio-Fragment Analyzing System 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 | 697514198AS246FL | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Allsheng Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000020502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 951c5daf-c5be-4b1e-a0f4-bf45aadda2c2 61 fields · synced Aug 3, 2026
- EUDAMED 4fc65281-1b64-4a35-9f4f-322def415864 61 fields · synced May 17, 2026