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Neonatal Heat Loss Prevention Suit Small/Medium/Large
EUDAMEDClass I (EU MDR)
Ref 44006Model Neonatal Heat Loss Prevention Suit Small/Medium/Large
Identity
- Trade Name
- Neonatal Heat Loss Prevention Suit Small/Medium/Large EUDAMED
- Device Name
- Neonatal Heat Loss Prevention Suit Small/Medium/Large EUDAMED
- Model / Reference
- Neonatal Heat Loss Prevention Suit Small/Medium/Large EUDAMED44006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095440063 EUDAMED
- Basic UDI-DI
- 890209544006F7 EUDAMED
- EMDN Code
- V028099 NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Neonatal Heat Loss Prevention Suit Small/Medium/Large by Poly Medicure Limited — 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 | 890209544006F7 | Class I | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000003380
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 03db7e42-e857-4e56-9ab0-295c0a47a767 61 fields · synced Jun 11, 2026