Identity
- Trade Name
- Urine analyzer EUDAMEDCONTEC FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- Urine Analyzer EUDAMEDFDA UDI
- Model / Reference
- BC401 EUDAMEDFDA UDIBC400 EUDAMED
- Description
- urine analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040101369 EUDAMEDFDA UDI06945040103363 EUDAMED
- Basic UDI-DI
- 69450401BC401AU EUDAMED69450401BC400AS EUDAMED
- Direct Marketing DI
- 06945040101369 EUDAMED06945040103363 EUDAMED
- FDA Product Code
- KQO FDA UDI
- EMDN Code
- W020101020102 SEMI-AUTOMATED URINE ANALYSERS EUDAMED
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2900 FDA UDI
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Urine analyzer by Contec Medical Systems Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69450401BC401AU | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (3)
- EUDAMED fb802b95-ed48-459e-8017-2eb4859603fa 61 fields · synced Jul 26, 2026
- EUDAMED 6aabaf74-c94c-431d-bcbd-392cf04f583b 61 fields · synced May 17, 2026
- FDA UDI b333360e-0cbd-4251-ba6f-737a87b80dbd 33 fields · synced May 30, 2026