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Urinalysis Strips
EUDAMEDClass IVD General (EU MDR)
Ref 3000321Model 100 strips/bottle (4 Item)Ref 3000255Model 100 strips/bottle (A10)Ref 3000211Model 100 strips/bottle (H11-MA)Ref 3000204Model 100 strips/bottle (H11-800MA)Ref 3000193Model 100 strips/bottle (H11-800)Ref 3000291Model 100 strips/bottle (H14-CA)Ref 3000359Model 100 strips/bottle (2 Item)Ref 3000157Model 100 strips/bottle (H13-CR)Ref 3002373Model 100 strips/bottle×10 + 1 IC card (FUS-10)Ref 3014875Model 100 strips/bottle×6 + 1 CPU card (H10)Ref 3000309Model 100 strips/bottle (H2-Cr)Ref 3000285Model 100 strips/bottle (H13-800CR)Ref 3014876Model 100 strips/bottle×6 + 1 CPU card (H14-Ca)Ref 3000195Model 100 strips/bottle×10 + 1 IC card (H11-800)Ref 3008634Model 100 strips/bottle×10 + 1 CPU card (FUS-11Ⅱ)Ref 3019032Model 100 strips/bottle×10 + 1 CPU card (H12-800MA)Ref 3008626Model 100 strips/bottle×10 + 1 CPU card (FUS-10Ⅱ)Ref 3008658Model 100 strips/bottle×10 + 1 CPU card (FUS-13CrⅡ)Ref 3008650Model 100 strips/bottle×10 + 1 CPU card (FUS-12MAⅡ)Ref 3000243Model 100 strips/bottle×10 + 1 IC card (H10-800)Ref 3019040Model 100 strips/bottle×10 + 1 CPU card (H13-800CR)Ref 3000316Model 100 strips/bottle (5 Item)Ref 3019037Model 100 strips/bottle×10 + 1 CPU card (H11-800MA)Ref 3000172Model 100 strips/bottle×10 + 1 IC card (H12-800MA)Ref 3019035Model 100 strips/bottle×10 + 1 CPU card (H11-800)
Identity
- Trade Name
- Urinalysis Strips EUDAMED
- Device Name
- Urinalysis Strips EUDAMED
- Model / Reference
- 100 strips/bottle (4 Item) EUDAMED3000321 EUDAMED100 strips/bottle (A10) EUDAMED3000255 EUDAMED100 strips/bottle (H11-MA) EUDAMED3000211 EUDAMED100 strips/bottle (H11-800MA) EUDAMED3000204 EUDAMED100 strips/bottle (H11-800) EUDAMED3000193 EUDAMED100 strips/bottle (H14-CA) EUDAMED3000291 EUDAMED100 strips/bottle (2 Item) EUDAMED3000359 EUDAMED100 strips/bottle (H13-CR) EUDAMED3000157 EUDAMED100 strips/bottle×10 + 1 IC card (FUS-10) EUDAMED3002373 EUDAMED100 strips/bottle×6 + 1 CPU card (H10) EUDAMED3014875 EUDAMED100 strips/bottle (H2-Cr) EUDAMED3000309 EUDAMED100 strips/bottle (H13-800CR) EUDAMED3000285 EUDAMED100 strips/bottle×6 + 1 CPU card (H14-Ca) EUDAMED3014876 EUDAMED100 strips/bottle×10 + 1 IC card (H11-800) EUDAMED3000195 EUDAMED100 strips/bottle×10 + 1 CPU card (FUS-11Ⅱ) EUDAMED3008634 EUDAMED100 strips/bottle×10 + 1 CPU card (H12-800MA) EUDAMED3019032 EUDAMED100 strips/bottle×10 + 1 CPU card (FUS-10Ⅱ) EUDAMED3008626 EUDAMED100 strips/bottle×10 + 1 CPU card (FUS-13CrⅡ) EUDAMED3008658 EUDAMED100 strips/bottle×10 + 1 CPU card (FUS-12MAⅡ) EUDAMED3008650 EUDAMED100 strips/bottle×10 + 1 IC card (H10-800) EUDAMED3000243 EUDAMED100 strips/bottle×10 + 1 CPU card (H13-800CR) EUDAMED3019040 EUDAMED100 strips/bottle (5 Item) EUDAMED3000316 EUDAMED100 strips/bottle×10 + 1 CPU card (H11-800MA) EUDAMED3019037 EUDAMED100 strips/bottle×10 + 1 IC card (H12-800MA) EUDAMED3000172 EUDAMED100 strips/bottle×10 + 1 CPU card (H11-800) EUDAMED3019035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794500236 EUDAMED06925794500090 EUDAMED06925794500281 EUDAMED06925794502131 EUDAMED06925794500304 EUDAMED06925794502469 EUDAMED06925794500175 EUDAMED06925794502155 EUDAMED16925794573640 EUDAMED06925794522825 EUDAMED06925794502179 EUDAMED06925794502421 EUDAMED06925794522863 EUDAMED06925794504067 EUDAMED16925794514827 EUDAMED06942202268212 EUDAMED16925794573664 EUDAMED16925794514858 EUDAMED16925794514841 EUDAMED06925794504050 EUDAMED06942202268205 EUDAMED06925794500137 EUDAMED06942202268175 EUDAMED06925794504098 EUDAMED06942202268199 EUDAMED
- Basic UDI-DI
- B-06925794500236 EUDAMEDB-06925794500090 EUDAMEDB-06925794500281 EUDAMEDB-06925794502131 EUDAMEDB-06925794500304 EUDAMEDB-06925794502469 EUDAMEDB-06925794500175 EUDAMEDB-06925794502155 EUDAMEDB-16925794573640 EUDAMEDB-06925794522825 EUDAMEDB-06925794502179 EUDAMEDB-06925794502421 EUDAMEDB-06925794522863 EUDAMEDB-06925794504067 EUDAMEDB-16925794514827 EUDAMEDB-06942202268212 EUDAMEDB-16925794573664 EUDAMEDB-16925794514858 EUDAMEDB-16925794514841 EUDAMEDB-06925794504050 EUDAMEDB-06942202268205 EUDAMEDB-06925794500137 EUDAMEDB-06942202268175 EUDAMEDB-06925794504098 EUDAMEDB-06942202268199 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMEDW0101060205 URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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 Strips by Dirui Industrial 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-06925794500236 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (25)
- EUDAMED b3fb0b40-3224-47ee-b988-6bcf47bd2bcc 61 fields · synced Aug 2, 2026
- EUDAMED 18eeb587-d7cc-41e3-839b-132fda41f9d0 61 fields · synced May 11, 2026
- EUDAMED ee3aba76-f5cf-4369-aeb4-5acfb62c2141 61 fields · synced May 16, 2026
- EUDAMED 9ef42e1e-265f-46dd-bf2f-c83e3cf569fc 61 fields · synced May 16, 2026
- EUDAMED 0b83e65d-2a14-41d0-b228-2adc9624bcd1 61 fields · synced May 16, 2026
- EUDAMED 90fe538e-49f7-47fd-8419-19380ef0e96a 61 fields · synced May 16, 2026
- EUDAMED 8ef64c18-5248-48d5-86b7-4793adcaf2b7 61 fields · synced May 17, 2026
- EUDAMED 00cba8b7-1dc0-4782-9990-c7c60251e157 61 fields · synced May 17, 2026
- EUDAMED 5a0c248a-1c0e-4da3-a41f-84c06b2c4168 61 fields · synced May 17, 2026
- EUDAMED d1137aaa-f67f-4621-b0b8-95291a2472f5 61 fields · synced May 17, 2026
- EUDAMED 87e92e5c-462e-4f84-8363-17995c1508e4 61 fields · synced May 18, 2026
- EUDAMED e7b1f39f-130a-4f78-9388-978a45c48671 61 fields · synced May 18, 2026
- EUDAMED 65f1a9cf-1f2a-4903-aec6-376fbd06a224 61 fields · synced May 18, 2026
- EUDAMED f7a10c8d-e79f-4cdf-9c4c-a364af6dd573 61 fields · synced Jul 8, 2026
- EUDAMED f62ab119-7286-42a6-a678-8fab629b1daf 61 fields · synced Jul 10, 2026
- EUDAMED d19e8266-fa3a-4bc9-8678-4da7a983a537 61 fields · synced Jul 10, 2026
- EUDAMED 06a0f225-b396-4dd6-9269-9ab62e638d90 61 fields · synced Jul 10, 2026
- EUDAMED cee5854e-6baf-44fa-8d0c-bdad4f1ab7ac 61 fields · synced Jul 17, 2026
- EUDAMED 82a77f37-2697-433c-8a5f-abcd798fcf4f 61 fields · synced Jul 19, 2026
- EUDAMED 9c854512-aa96-487a-8435-3eeabbbe314b 61 fields · synced Jul 20, 2026
- EUDAMED 6b0c517f-3e51-4008-9fa3-4a8229249a4e 61 fields · synced Jul 24, 2026
- EUDAMED 3a4110e7-74b2-4f67-94d8-a8267e572078 61 fields · synced Jul 24, 2026
- EUDAMED e2ba1450-20f7-406e-ba06-a2b7a4190063 61 fields · synced Jul 27, 2026
- EUDAMED 2e41c109-21fe-4074-a205-d705b893872f 61 fields · synced Jul 31, 2026
- EUDAMED 8ad3919d-8e49-413a-8853-a3ee6eeb184f 61 fields · synced Aug 2, 2026