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Fecal Morphology Quality Control
EUDAMEDClass A (EU MDR)
Ref 3.0mL/bottle×5Model 2.0mL/bottle×5, 2.0mL/bottle×10, 3.0mL/bottle×5, 4.0mL/bottle×2, 4.0mL/bottle×4
Identity
- Trade Name
- Fecal Morphology Quality Control EUDAMED
- Device Name
- Fecal Morphology Quality Control EUDAMED
- Model / Reference
- 2.0mL/bottle×5, 2.0mL/bottle×10, 3.0mL/bottle×5, 4.0mL/bottle×2, 4.0mL/bottle×4 EUDAMED3.0mL/bottle×5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522648964 EUDAMED
- Basic UDI-DI
- 697052264SJPOZ0008VP EUDAMED
- Direct Marketing DI
- 06970522648964 EUDAMED
- EMDN Code
- W0101060399 FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Fecal Morphology Quality Control by Sichuan Orienter 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 | 697052264SJPOZ0008VP | Class A | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 771a8f79-04ab-41f7-b66b-3a9dc704eb39 61 fields · synced Jun 19, 2026