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Urinalysis Strips
EUDAMEDClass IVD General (EU MDR)
Ref URS-2TRef URS-1TRef URS-4TRef URS-9TRef URS-6TRef URS-13TRef URS-5TRef URS-7T
Identity
- Trade Name
- Urinalysis Strips EUDAMED
- Device Name
- Urinalysis Strips EUDAMED
- Model / Reference
- URS-2T EUDAMEDURS-1T EUDAMEDURS-4T EUDAMEDURS-9T EUDAMEDURS-6T EUDAMEDURS-13T EUDAMEDURS-5T EUDAMEDURS-7T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-URS-2TN4 EUDAMEDD-URS-1TMZ EUDAMEDD-URS-4TNA EUDAMEDD-URS-9TNR EUDAMEDD-URS-6TNG EUDAMEDD-URS-13T7Y EUDAMEDD-URS-5TND EUDAMEDD-URS-7TNK EUDAMED
- Basic UDI-DI
- B-URS-2TN4 EUDAMEDB-URS-1TMZ EUDAMEDB-URS-4TNA EUDAMEDB-URS-9TNR EUDAMEDB-URS-6TNG EUDAMEDB-URS-13T7Y EUDAMEDB-URS-5TND EUDAMEDB-URS-7TNK EUDAMED
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
Urinalysis Strips by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-URS-2TN4 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (8)
- EUDAMED 822c2ae5-05b9-45e9-9d0e-49f88c04bd29 61 fields · synced Oct 5, 2026
- EUDAMED 042610c1-62fe-47f2-b13d-71bdc6b2ca48 61 fields · synced May 18, 2026
- EUDAMED 80d004f3-ac49-4b2a-8874-9a75e1b84bdf 61 fields · synced May 19, 2026
- EUDAMED a21772b2-d473-4156-b77c-4d09377d31fe 61 fields · synced Jun 18, 2026
- EUDAMED f59ab991-bdff-4fef-a454-15c0bf551516 61 fields · synced Jul 13, 2026
- EUDAMED b2d51289-62e1-43f8-a8f0-ac2a6b75d5d4 61 fields · synced Jul 15, 2026
- EUDAMED 5d722c33-62f9-4942-bd95-f93bcea6820c 61 fields · synced Jul 18, 2026
- EUDAMED edbbded6-16a4-4e78-a448-5715c1a8e263 61 fields · synced Aug 4, 2026