← Back to catalogue
Flexitol Heel Balm
EUDAMEDClass IIa (EU MDR)
Ref 183475 (56g)Model Flexitol Cracked Heel Balm OTC
Identity
- Device Name
- Flexitol Heel Balm EUDAMED
- Model / Reference
- Flexitol Cracked Heel Balm OTC EUDAMED183475 (56g) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05011309138016 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thornton & Ross Ltd
- EUDAMED SRN
- GB-MF-000009462
- Authorised Representative
- HÄLSA Pharma GmbH DE-AR-000007406
Sources (1)
- EUDAMED f70c6d0c-a6c0-476c-a9e5-eeb21b158c3e 61 fields · synced Jun 18, 2026