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Urinalysis Sheath Fluid
EUDAMEDClass A (EU MDR)
Ref NY4001Y1Model Urinalysis Sheath Fluid
Identity
- Trade Name
- Urinalysis Sheath Fluid EUDAMED
- Device Name
- Urinalysis Sheath Fluid EUDAMED
- Model / Reference
- Urinalysis Sheath Fluid EUDAMEDNY4001Y1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595749809 EUDAMED
- Basic UDI-DI
- 693659574001N6 EUDAMED
- EMDN Code
- W0101060299 URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Urinalysis Sheath Fluid by Medicalsystem 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 | 693659574001N6 | Class A | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d85a5e8a-f150-4c9e-a9b4-b2445d077116 61 fields · synced Jul 13, 2026