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Flexitol Heel Balm
EUDAMEDClass IIa (EU MDR)
Ref 183471 (112g)Model Flexitol Cracked Heel Balm OTC Ref 322086 (40g)
Identity
- Device Name
- Flexitol Heel Balm EUDAMED
- Model / Reference
- Flexitol Cracked Heel Balm OTC EUDAMED183471 (112g) EUDAMED322086 (40g) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05011309137910 EUDAMED05011309151312 EUDAMED
- Basic UDI-DI
- 5011309SkinTreatmentDF EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Flexitol Heel Balm by Thornton & Ross 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 | 5011309SkinTreatmentDF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Thornton & Ross Ltd
- EUDAMED SRN
- GB-MF-000009462
- Authorised Representative
- HÄLSA Pharma GmbH DE-AR-000007406
Sources (2)
- EUDAMED 90572371-e572-4898-becc-61dd161788d3 61 fields · synced Jul 10, 2026
- EUDAMED 1ac9f879-f516-4bb4-9098-1a78d356803c 61 fields · synced May 17, 2026