← Back to catalogue
Urine Strip
EUDAMEDClass IVD General (EU MDR)
Ref URS-11HRef URS-14HRef URS-14FRef URS-10HRef URS-11FRef URS-10F
Identity
- Trade Name
- Urine Strip EUDAMED
- Device Name
- Urine Strip EUDAMED
- Model / Reference
- URS-11H EUDAMEDURS-14H EUDAMEDURS-14F EUDAMEDURS-10H EUDAMEDURS-11F EUDAMEDURS-10F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974410142060 EUDAMED06974410142077 EUDAMED06974410142091 EUDAMED06974410142015 EUDAMED06974410142084 EUDAMED06974410142022 EUDAMED
- Basic UDI-DI
- B-06974410142060 EUDAMEDB-06974410142077 EUDAMEDB-06974410142091 EUDAMEDB-06974410142015 EUDAMEDB-06974410142084 EUDAMEDB-06974410142022 EUDAMED
- EMDN Code
- W01010901 URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Urine Strip by Bioway Biological Technology 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-06974410142060 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioway Biological Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000026464
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED d4b51330-e4ef-4734-a851-da97191ea4ee 61 fields · synced Jul 21, 2026
- EUDAMED b4ac4168-b9a5-4ff6-9cdb-f3932ae3c8fb 61 fields · synced May 17, 2026
- EUDAMED 654269ff-a44d-47bc-a2af-d53f41955c83 61 fields · synced May 17, 2026
- EUDAMED 71e3fd77-4534-4024-a29b-4731732121c7 61 fields · synced May 17, 2026
- EUDAMED 554541e3-63a0-4e74-9797-cf8769c1b9dc 61 fields · synced May 18, 2026
- EUDAMED d8b9688c-f189-4ec0-accb-1f1bf19d74de 61 fields · synced May 18, 2026