Identity
- Device Name
- Bilirubinmeter EUDAMED
- Model / Reference
- CAT-1005-3.2 EUDAMEDCAT-1004-3.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987848013002 EUDAMED04987848012005 EUDAMED
- Basic UDI-DI
- 4987848Bilirubin_AV3 EUDAMED
- Direct Marketing DI
- 04987848013002 EUDAMED04987848012005 EUDAMED
- EMDN Code
- W0201069004 BILIRUBINOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Bilirubinmeter by APEL Co., LTD.JAPAN — 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 | 4987848Bilirubin_AV3 | Class A | Active |
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Manufacturer
- Manufacturer
- APEL Co., LTD.JAPAN
- EUDAMED SRN
- JP-MF-000023982
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 220f9ad4-47e9-46e8-b61e-f6300233fe64 61 fields · synced Jul 29, 2026
- EUDAMED 8271d839-5ccc-4a82-95bf-712abd195b80 61 fields · synced May 18, 2026