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Urinalysis Reagent Strips
EUDAMEDClass IVD General (EU MDR)
Ref URS-140Ref URS-022
Identity
- Trade Name
- URINALYSIS REAGENT STRIPS EUDAMED
- Device Name
- URINALYSIS REAGENT STRIPS EUDAMED
- Model / Reference
- URS-140 EUDAMEDURS-022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663985024 EUDAMED06939663985109 EUDAMED
- Basic UDI-DI
- B-06939663985024 EUDAMEDB-06939663985109 EUDAMED
- EMDN Code
- W01010499 MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Urinalysis Reagent Strips by Sejoy Biomedical 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-06939663985024 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 9f93d35f-c5c0-4e72-b456-c8ddf5488b2d 61 fields · synced Jul 14, 2026
- EUDAMED 541f94cc-578f-476d-8fc3-6fbf7deec375 61 fields · synced May 17, 2026