Identity
- Trade Name
- IDkit Hp® One EUDAMED
- Device Name
- IDcircuit® (IDkit Hp® One) EUDAMED
- Model / Reference
- VS09004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290016923216 EUDAMED
- Basic UDI-DI
- 7290016923VS0814399 EUDAMED
- Unit of Use DI
- 37290016923217 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IDkit Hp® One by Meridian Bioscience Israel Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290016923VS0814399 | Class I | Active |
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Manufacturer
- Manufacturer
- Meridian Bioscience Israel Ltd.
- EUDAMED SRN
- IL-MF-000034713
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (1)
- EUDAMED b2543181-18f4-4c37-931a-2c9de1e14e0d 61 fields · synced Jun 19, 2026