← Back to catalogue
ZODMED Test ciazowy
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACK21001-C02-016Model CassetteRef ACK21001-M02-016Model Midstream
Identity
- Trade Name
- ZODMED Test ciazowy EUDAMED
- Device Name
- HCG Pregnancy Tests EUDAMED
- Model / Reference
- Cassette EUDAMEDACK21001-C02-016 EUDAMEDMidstream EUDAMEDACK21001-M02-016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942468135020 EUDAMED06942468135037 EUDAMED
- Basic UDI-DI
- B-06942468135020 EUDAMEDB-06942468135037 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ZODMED Test ciazowy by Core Technology Co., Ltd. — Class IVD devices for self-testing — 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-06942468135020 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Core Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023522
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 7580653f-c4f1-4e91-9655-298e57dc3cd7 61 fields · synced Jul 26, 2026
- EUDAMED b8e06058-c6d5-4338-9f30-d40f31f1b043 61 fields · synced May 19, 2026