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Specifications：4.5L、Specifications：9L
EUDAMEDClass A (EU MDR)
Ref 7600-PA00004Model Cuvette Wash Solution
Identity
- Trade Name
- Specifications：4.5L、Specifications：9L EUDAMED
- Device Name
- Cuvette Wash Solution EUDAMED
- Model / Reference
- Cuvette Wash Solution EUDAMED7600-PA00004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978066773999 EUDAMED
- Basic UDI-DI
- 697806677OT002QM EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - 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
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Specifications：4.5L、Specifications：9L by Shenzhen CoooSeee Biomedical 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 | 697806677OT002QM | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen CoooSeee Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000045646
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 48e9296f-b32e-4a79-aac9-5b03176ff7f9 61 fields · synced Jul 26, 2026