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ConcizuTrace™ Sample Collection Kit
EUDAMEDClass A (EU MDR)
Ref CZM10601Ref CZM10597 Ref CZM10594Ref CZM10743Ref CZM10744Ref CZM10598Ref CZM10655Ref CZM10742Ref CZM10595
Identity
- Trade Name
- ConcizuTrace™ Sample Collection Kit EUDAMED
- Device Name
- ConcizuTrace™ Sample Collection Kit EUDAMED
- Model / Reference
- CZM10601 EUDAMEDCZM10597 EUDAMEDCZM10594 EUDAMEDCZM10743 EUDAMEDCZM10744 EUDAMEDCZM10598 EUDAMEDCZM10655 EUDAMEDCZM10742 EUDAMEDCZM10595 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273218978 EUDAMED05055273218909 EUDAMED05055273218879 EUDAMED05055273220698 EUDAMED05055273220704 EUDAMED05055273218916 EUDAMED05055273219272 EUDAMED05055273220681 EUDAMED05055273218886 EUDAMED
- Basic UDI-DI
- 50552732ACTSCKT047KQ EUDAMED
- EMDN Code
- W0501010199 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland EUDAMEDBelgium 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
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMEDEUDAMED
ConcizuTrace™ Sample Collection Kit by Randox Laboratories Limited — 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 | 50552732ACTSCKT047KQ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (9)
- EUDAMED a2990c51-c667-4712-ab38-453078d44cb1 61 fields · synced Jul 31, 2026
- EUDAMED bcbe74e9-6cd9-4df6-b76f-6b0de91aa0ae 61 fields · synced May 16, 2026
- EUDAMED 7023ef51-6e07-4fe6-a54c-af837f2f0e0d 61 fields · synced May 17, 2026
- EUDAMED 8b25cdc8-88a9-4135-976a-d4aa553f5683 61 fields · synced May 17, 2026
- EUDAMED 3fcd1c70-d552-4f83-8a98-18ac1eb362ce 61 fields · synced May 17, 2026
- EUDAMED 4e379aaa-7056-4c23-9683-08b5a0377459 61 fields · synced May 17, 2026
- EUDAMED ba9a09d3-eb57-408a-be57-5f01761085cc 61 fields · synced May 17, 2026
- EUDAMED 1f190176-b4f4-4962-bd57-dc042fb499da 61 fields · synced May 18, 2026
- EUDAMED ebd1a850-6b43-4eab-9fe5-48060df2f290 61 fields · synced May 19, 2026