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Aucheer YH-061 Test cartridge incubator
EUDAMEDClass A (EU MDR)
Ref LYH61Model YH-061
Identity
- Trade Name
- Aucheer YH-061 Test cartridge incubator EUDAMED
- Device Name
- Aucheer YH-061 Test cartridge incubator EUDAMED
- Model / Reference
- YH-061 EUDAMEDLYH61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974546541263 EUDAMED
- Basic UDI-DI
- 0697454654LYH61CW EUDAMED
- Direct Marketing DI
- 06974546541263 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Aucheer YH-061 Test cartridge incubator by Ningbo Aucheer Biotechnology 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 | 0697454654LYH61CW | Class A | Active |
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Manufacturer
- Manufacturer
- Ningbo Aucheer Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038081
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED c1929c05-5d24-429e-878e-2cb1eda6e14a 61 fields · synced Jul 9, 2026