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Specimen Collection Kit
EUDAMEDClass A (EU MDR)
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Identity
- Device Name
- Specimen Collection Kit EUDAMED
- Model / Reference
- S2:20preps/bag EUDAMEDL:20preps/bag EUDAMEDS1:100preps/bag EUDAMEDB:50preps/bag EUDAMEDS1:1preps/bag EUDAMEDS2:200preps/bag EUDAMEDS1:50preps/bag EUDAMEDS2:1preps/bag EUDAMEDB:100preps/bag EUDAMEDS1:200preps/bag EUDAMEDB:200preps/bag EUDAMEDS2:100preps/bag EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974898111275 EUDAMED06974898111176 EUDAMED06974898111244 EUDAMED06974898111138 EUDAMED06974898111213 EUDAMED06974898111305 EUDAMED06974898111237 EUDAMED06974898111268 EUDAMED06974898111145 EUDAMED06974898111251 EUDAMED06974898111152 EUDAMED06974898111299 EUDAMED
- Basic UDI-DI
- 697489811000007ZG EUDAMED
- Direct Marketing DI
- 06974898111275 EUDAMED06974898111176 EUDAMED06974898111244 EUDAMED06974898111138 EUDAMED06974898111213 EUDAMED06974898111305 EUDAMED06974898111237 EUDAMED06974898111268 EUDAMED06974898111145 EUDAMED06974898111251 EUDAMED06974898111152 EUDAMED06974898111299 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Specimen Collection Kit by Genfine Biotech(changzhou) Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697489811000007ZG | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genfine Biotech(changzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000003399
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (12)
- EUDAMED 6a8ef292-39e4-4047-9ffc-2bfacff95ecc 61 fields · synced Oct 6, 2026
- EUDAMED 09985ec9-b879-4a56-85ed-1ad35aab53c3 61 fields · synced May 11, 2026
- EUDAMED 251aca3f-57be-4592-9d2e-d10240c95044 61 fields · synced May 16, 2026
- EUDAMED e6624717-310a-4e61-bd86-f7c9a8838da9 61 fields · synced May 16, 2026
- EUDAMED a980f07a-44d2-48cb-90e9-53c8dece1599 61 fields · synced May 16, 2026
- EUDAMED 0fff2107-ab59-4f01-922b-87755d6904ec 61 fields · synced May 17, 2026
- EUDAMED ee808941-e221-49db-b3e0-ee7a8fb49b77 61 fields · synced May 17, 2026
- EUDAMED ff1effb4-c906-4d67-84bd-389d4aa7a96f 61 fields · synced May 17, 2026
- EUDAMED bd7421fb-d142-4309-889c-75b831e47906 61 fields · synced May 18, 2026
- EUDAMED 15d1648e-483c-4a0b-9d84-976f7e30873f 61 fields · synced May 18, 2026
- EUDAMED f59d5d70-4ee1-4822-856f-72bdd6ef43da 61 fields · synced May 18, 2026
- EUDAMED 1c213f0f-bb65-4e81-88aa-e7574812bb25 61 fields · synced May 19, 2026