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cence
EUDAMEDClass A (EU MDR)
Ref F-12KModel F-12K, F-24K, F-36K, MG2020, MG2040, BMG2024, VG10K, XY10S
by Hunan Xiang Yi Laboratory Instrument Development Co., Ltd.
Identity
- Trade Name
- cence EUDAMED
- Device Name
- INCUBATOR EUDAMED
- Model / Reference
- F-12K, F-24K, F-36K, MG2020, MG2040, BMG2024, VG10K, XY10S EUDAMEDF-12K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971402971516 EUDAMED
- Basic UDI-DI
- 697140297XYINC243LE EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
EUDAMED
cence by Hunan Xiang Yi Laboratory Instrument Development 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 | 697140297XYINC243LE | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000036982
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d3d9fe26-2d25-4952-8309-751600da571b 61 fields · synced Jun 18, 2026