Identity
- Device Name
- Dry Chemistry Analyzer EUDAMED
- Model / Reference
- SHA-100, SHA-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861681630 EUDAMED
- Basic UDI-DI
- 6973861681630F6 EUDAMED
- EMDN Code
- W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Dry Chemistry Analyzer by Anbio (Xiamen) 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 | 6973861681630F6 | Class A | Active |
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Manufacturer
- Manufacturer
- Anbio (Xiamen) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023936
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 04c38409-6197-4aac-ad28-1c5458e2cf53 61 fields · synced Jul 31, 2026
- EUDAMED 04c38409-6197-4aac-ad28-1c5458e2cf53-1 61 fields · synced Jun 9, 2026