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Fully Automatic Chemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref BC0204Model iBC 900-ARef BC0244Ref BC0212
Identity
- Device Name
- Fully Automatic Chemistry Analyzer EUDAMED
- Model / Reference
- iBC 900-A EUDAMEDBC0204 EUDAMEDBC0244 EUDAMEDBC0212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912734451 EUDAMED06925912734857 EUDAMED06925912720553 EUDAMED
- Basic UDI-DI
- 692591270282HP EUDAMED
- EMDN Code
- W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400) 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
Fully Automatic Chemistry Analyzer by Shenzhen Yhlo Biotech 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 | 692591270282HP | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 0e257a73-1a83-41fe-9972-438de46339a7 61 fields · synced Aug 5, 2026
- EUDAMED b7a6b399-8b9a-4a95-bdf2-c1e931c07bda 61 fields · synced May 19, 2026
- EUDAMED d7f379c9-7f02-44a2-9b63-ea541f4a6de5 61 fields · synced Jul 9, 2026