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Urine Analyzer H-100
EUDAMEDClass A (EU MDR)
Ref 3010996Model H-100,H-500,HC-300Ref 3006456Ref 3018644Ref H-1600Ref H-800
Identity
- Trade Name
- Urine Analyzer H-100 EUDAMEDUrine Analyzer EUDAMED
- Device Name
- Urine Analyzer EUDAMED
- Model / Reference
- H-100,H-500,HC-300 EUDAMED3010996 EUDAMED3006456 EUDAMED3018644 EUDAMEDH-1600 EUDAMEDH-800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576385 EUDAMED06925794576354 EUDAMED06925794576361 EUDAMED06925794520098 EUDAMED06925794504517 EUDAMED
- Basic UDI-DI
- 69257945W020101020102D0B3 EUDAMEDB-06925794520098 EUDAMEDB-06925794504517 EUDAMED
- EMDN Code
- W020101020102 SEMI-AUTOMATED URINE ANALYSERS EUDAMEDW020101020103 AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Poland 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
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Urine Analyzer H-100 by Dirui Industrial Co., Ltd — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69257945W020101020102D0B3 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 69257945W020101020102D0B3 | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 8cdaaec9-88ff-41a8-a871-e8a231b58f99 61 fields · synced Aug 2, 2026
- EUDAMED 19c30335-58e3-4268-a61c-33f30e800c06 61 fields · synced May 17, 2026
- EUDAMED 5da0094e-5ea1-44f2-a2be-b2bf69b2e46b 61 fields · synced May 17, 2026
- EUDAMED 01f2a59d-5ab2-4a17-a0d3-27b1d67d5e82 61 fields · synced Jun 18, 2026
- EUDAMED a84e54ee-ad2a-48e9-bf8c-6fca7d5ec53a 61 fields · synced Jul 10, 2026