Incubator
by Hunan Xiang Yi Laboratory Instrument Development Co., Ltd. EUDAMED
Active
Ref MG2020Model F-12K, F-24K, F-36K, MG2020, MG2040, BMG2024, VG10K, XY10S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697140297XYINC243LE | Date28 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Incubator
- Model / Reference
- F-12K, F-24K, F-36K, MG2020, MG2040, BMG2024, VG10K, XY10S
- Primary DI / UDI-DI
- 06971402972179
- Basic UDI-DI
- 697140297XYINC243LE
- EMDN Code
- W0599 IVD general use consumable devices - other
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000036982
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No