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EUDAMEDClass A (EU MDR)
Ref H2050R-1Model TDZ4-WS,TD4,LT53,TD3,L550,TDZ5-WS,L420-A,L500-A,L600-A,XKA-2200, TG12M,TXD3,TDZ4K,CH12R,CH16R,CHT210,HT190,H1850,H1650,TG16-WS, H1750R,HT165R,CL8R,CL5R,CL5 ,DL-6M,HT190R,L530R,HT200,H1750,HT165,H1650K,TGL-16, H1650-W,M16,TD-24K, PRP400,PRP500,L720R-3,etc.
by Hunan Xiang Yi Laboratory Instrument Development Co., Ltd.
Identity
- Trade Name
- cence EUDAMED
- Device Name
- CENTRIFUGE EUDAMED
- Model / Reference
- TDZ4-WS,TD4,LT53,TD3,L550,TDZ5-WS,L420-A,L500-A,L600-A,XKA-2200, TG12M,TXD3,TDZ4K,CH12R,CH16R,CHT210,HT190,H1850,H1650,TG16-WS, H1750R,HT165R,CL8R,CL5R,CL5 ,DL-6M,HT190R,L530R,HT200,H1750,HT165,H1650K,TGL-16, H1650-W,M16,TD-24K, PRP400,PRP500,L720R-3,etc. EUDAMEDH2050R-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971402970199 EUDAMED
- Basic UDI-DI
- 697140297XYCEN0205WE EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: General-purpose centrifuge IVD
cence by Hunan Xiang Yi Laboratory Instrument Development Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697140297XYCEN0205WE | 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 08e25a45-e56e-4daa-a674-f9d7e81b9f56 61 fields · synced Jun 18, 2026