Identity
- Device Name
- Neonatal Phototherapy Unit EUDAMED
- Model / Reference
- BT-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012340017 EUDAMED
- Basic UDI-DI
- B-08800012340017 EUDAMED
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Neonatal Phototherapy Unit by Bistos Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800012340017 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bistos Co., Ltd.
- EUDAMED SRN
- KR-MF-000035951
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c2d1fb28-110f-42ee-93bc-a03aded7b0bf 61 fields · synced Jun 19, 2026