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Heltes
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref A01-02-122HT1Model Cassette
Identity
- Trade Name
- Heltes EUDAMED
- Device Name
- Human Chorionic Gonadotropin (HCG) Test Kits for self-testing (Ultra-sensitive) EUDAMED
- Model / Reference
- Cassette EUDAMEDA01-02-122HT1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347568184 EUDAMED
- Basic UDI-DI
- B-00628347568184 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Heltes by Artron Laboratories Inc. — 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-00628347568184 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED b8832126-57db-474a-969f-7f328a3d910f 61 fields · synced Jul 20, 2026