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BiliSwaddler
EUDAMEDClass I (EU MDR)
Ref 20-00-100Model Swaddler for fibreoptic phototherapy pads
by conceptnatal
Identity
- Trade Name
- BiliSwaddler EUDAMED
- Device Name
- BiliSwadddler EUDAMED
- Model / Reference
- Swaddler for fibreoptic phototherapy pads EUDAMED20-00-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260598172008 EUDAMED
- Basic UDI-DI
- 42605981720BILISWADDLERK5 EUDAMED
- Direct Marketing DI
- 04260598172008 EUDAMED
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
BiliSwaddler by conceptnatal — 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 | 42605981720BILISWADDLERK5 | Class I | Active |
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Manufacturer
- Manufacturer
- conceptnatal
- EUDAMED SRN
- DE-MF-000010321
Sources (1)
- EUDAMED bb8c39b0-77f6-495a-becc-8830a1e2b34a 61 fields · synced Jun 19, 2026