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Hot and Cold Breast Therapy Packs
EUDAMEDClass I (EU MDR)
Ref B0FHYJ7HXFModel Hot and Cold Breast Therapy PacksRef MG-SKN-BTP01-SM
by Fbgc Limited
Identity
- Trade Name
- Hot and Cold Breast Therapy Packs EUDAMED
- Device Name
- Hot and Cold Breast Therapy Packs EUDAMED
- Model / Reference
- Hot and Cold Breast Therapy Packs EUDAMEDB0FHYJ7HXF EUDAMEDMG-SKN-BTP01-SM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060551222509 EUDAMED05060551222851 EUDAMED
- Basic UDI-DI
- 506055122Hot-ColdPacksKP EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMEDGermany 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
Category: Device sterilization/disinfection container, reusable
Hot and Cold Breast Therapy Packs by Fbgc Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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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 | 506055122Hot-ColdPacksKP | Class I | Active |
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Manufacturer
- Manufacturer
- Fbgc Limited
- EUDAMED SRN
- UK-MF-000046785
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED 7d99e0b2-bf42-4ab3-b2a3-e383b397b421 61 fields · synced Jul 15, 2026
- EUDAMED f533c991-6229-486a-ae36-20859e3260fb 61 fields · synced Jul 15, 2026