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Infant Heel warmer
EUDAMEDClass IIa (EU MDR)
Ref 94245/IFW94245Model 44346/INH44346Ref 94235/IFW94235Ref IFW40000
Identity
- Trade Name
- Infant Heel warmer EUDAMED
- Device Name
- Instant hot/warm pack EUDAMED
- Model / Reference
- 44346/INH44346 EUDAMED94245/IFW94245 EUDAMED94235/IFW94235 EUDAMEDIFW40000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00064317942453 EUDAMED00064317942354 EUDAMED00064317400007 EUDAMED
- Basic UDI-DI
- 64317ravinsthot1EA EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMEDGreece EUDAMEDFrance 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
Infant Heel warmer by Rapid Aid Vietnam Co., Ltd — Class IIa — 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 | 64317ravinsthot1EA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Rapid Aid Vietnam Co., Ltd
- EUDAMED SRN
- VN-MF-000033576
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 10af53fa-9a58-404c-9763-2d984b0f0012 61 fields · synced Jul 17, 2026
- EUDAMED 700de282-c872-4248-8ef6-1b114a9f5a76 61 fields · synced May 18, 2026
- EUDAMED 573b4e8c-9355-4713-91db-994b65b59f68 61 fields · synced May 18, 2026