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Urinalysis Strips

EUDAMED

Class 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)

by Dirui Industrial Co., Ltd

Identity

Trade Name
Urinalysis Strips EUDAMED
Device Name
Urinalysis Strips EUDAMED
Model / Reference
100 strips/bottle (4 Item) EUDAMED
3000321 EUDAMED
100 strips/bottle (A10) EUDAMED
3000255 EUDAMED
100 strips/bottle (H11-MA) EUDAMED
3000211 EUDAMED
100 strips/bottle (H11-800MA) EUDAMED
3000204 EUDAMED
100 strips/bottle (H11-800) EUDAMED
3000193 EUDAMED
100 strips/bottle (H14-CA) EUDAMED
3000291 EUDAMED
100 strips/bottle (2 Item) EUDAMED
3000359 EUDAMED
100 strips/bottle (H13-CR) EUDAMED
3000157 EUDAMED
100 strips/bottle×10 + 1 IC card (FUS-10) EUDAMED
3002373 EUDAMED
100 strips/bottle×6 + 1 CPU card (H10) EUDAMED
3014875 EUDAMED
100 strips/bottle (H2-Cr) EUDAMED
3000309 EUDAMED
100 strips/bottle (H13-800CR) EUDAMED
3000285 EUDAMED
100 strips/bottle×6 + 1 CPU card (H14-Ca) EUDAMED
3014876 EUDAMED
100 strips/bottle×10 + 1 IC card (H11-800) EUDAMED
3000195 EUDAMED
100 strips/bottle×10 + 1 CPU card (FUS-11Ⅱ) EUDAMED
3008634 EUDAMED
100 strips/bottle×10 + 1 CPU card (H12-800MA) EUDAMED
3019032 EUDAMED
100 strips/bottle×10 + 1 CPU card (FUS-10Ⅱ) EUDAMED
3008626 EUDAMED
100 strips/bottle×10 + 1 CPU card (FUS-13CrⅡ) EUDAMED
3008658 EUDAMED
100 strips/bottle×10 + 1 CPU card (FUS-12MAⅡ) EUDAMED
3008650 EUDAMED
100 strips/bottle×10 + 1 IC card (H10-800) EUDAMED
3000243 EUDAMED
100 strips/bottle×10 + 1 CPU card (H13-800CR) EUDAMED
3019040 EUDAMED
100 strips/bottle (5 Item) EUDAMED
3000316 EUDAMED
100 strips/bottle×10 + 1 CPU card (H11-800MA) EUDAMED
3019037 EUDAMED
100 strips/bottle×10 + 1 IC card (H12-800MA) EUDAMED
3000172 EUDAMED
100 strips/bottle×10 + 1 CPU card (H11-800) EUDAMED
3019035 EUDAMED

Identifiers

Primary DI / UDI-DI
06925794500236 EUDAMED
06925794500090 EUDAMED
06925794500281 EUDAMED
06925794502131 EUDAMED
06925794500304 EUDAMED
06925794502469 EUDAMED
06925794500175 EUDAMED
06925794502155 EUDAMED
16925794573640 EUDAMED
06925794522825 EUDAMED
06925794502179 EUDAMED
06925794502421 EUDAMED
06925794522863 EUDAMED
06925794504067 EUDAMED
16925794514827 EUDAMED
06942202268212 EUDAMED
16925794573664 EUDAMED
16925794514858 EUDAMED
16925794514841 EUDAMED
06925794504050 EUDAMED
06942202268205 EUDAMED
06925794500137 EUDAMED
06942202268175 EUDAMED
06925794504098 EUDAMED
06942202268199 EUDAMED
Basic UDI-DI
B-06925794500236 EUDAMED
B-06925794500090 EUDAMED
B-06925794500281 EUDAMED
B-06925794502131 EUDAMED
B-06925794500304 EUDAMED
B-06925794502469 EUDAMED
B-06925794500175 EUDAMED
B-06925794502155 EUDAMED
B-16925794573640 EUDAMED
B-06925794522825 EUDAMED
B-06925794502179 EUDAMED
B-06925794502421 EUDAMED
B-06925794522863 EUDAMED
B-06925794504067 EUDAMED
B-16925794514827 EUDAMED
B-06942202268212 EUDAMED
B-16925794573664 EUDAMED
B-16925794514858 EUDAMED
B-16925794514841 EUDAMED
B-06925794504050 EUDAMED
B-06942202268205 EUDAMED
B-06925794500137 EUDAMED
B-06942202268175 EUDAMED
B-06925794504098 EUDAMED
B-06942202268199 EUDAMED
EMDN Code
W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
W0101060205 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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