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Fima Global Brands
EUDAMEDClass I (EU MDR)
Ref PE026Ref PE040XXLModel Elasticated- Hand SupportRef PE040Ref PE033-XXLRef PE030Ref PE021Ref PE039Ref PE037Ref PE022Ref PE038Ref PE025
Identity
- Trade Name
- Fima Global Brands EUDAMED
- Device Name
- Elastic Ankle Support EUDAMEDPREMIA® - Elasticated- Hand Support EUDAMEDElastic Elbow Support (S) – Beige EUDAMEDPREMIA – ELASTIC ACTIVE WRIST/HAND SUPPORT EUDAMEDElastic Knee Support EUDAMED
- Model / Reference
- PE026 EUDAMEDElasticated- Hand Support EUDAMEDPE040XXL EUDAMEDPE040 EUDAMEDPE033-XXL EUDAMEDPE030 EUDAMEDPE021 EUDAMEDPE039 EUDAMEDPE037 EUDAMEDPE022 EUDAMEDPE038 EUDAMEDPE025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982420260 EUDAMED05060982420444 EUDAMED05060982420437 EUDAMED05060982420345 EUDAMED05060982420314 EUDAMED05060982420703 EUDAMED05060982420420 EUDAMED05060982420406 EUDAMED05060982420710 EUDAMED05060982420413 EUDAMED05060982420253 EUDAMED05060982420208 EUDAMED
- Basic UDI-DI
- 506098242PE025-0284X EUDAMED506098242PE037-0405Q EUDAMED506098242PE029-03262 EUDAMED506098242PEA021-024M9 EUDAMED506098242PE021-0243B EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMEDY060606 HAND ORTHOSES EUDAMEDY060615 ELBOW ORTHOSES EUDAMEDY060612 WRIST-HAND ORTHOSES EUDAMEDY061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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: Ankle/foot orthosis
Fima Global Brands by Fima Global Brands Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 506098242PE025-0284X | Class I | Active |
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Manufacturer
- Manufacturer
- Fima Global Brands Ltd
- EUDAMED SRN
- UK-MF-000036604
- Authorised Representative
- GLORY-Cosmetic Hungary Kft. HU-AR-000035374
Sources (12)
- EUDAMED 6362479a-b738-454b-bd19-4152baff0b02 61 fields · synced Aug 2, 2026
- EUDAMED 1401665a-8af7-4d1c-b398-53959ea5105f 61 fields · synced May 16, 2026
- EUDAMED 63f86cca-74c7-4294-885e-2ab819beffa8 61 fields · synced May 17, 2026
- EUDAMED d4ce77fc-2e5e-457e-8ec6-2d23056cc299 61 fields · synced May 17, 2026
- EUDAMED adf0505e-c44a-4256-b0f6-a7d31d1dac35 61 fields · synced May 17, 2026
- EUDAMED ef216107-a33c-46a0-817f-6e091d4acc38 61 fields · synced May 17, 2026
- EUDAMED 955f2692-3985-4645-96b6-645262f5589c 61 fields · synced May 18, 2026
- EUDAMED 6fd1c905-32b9-4f60-ae8e-a47cf175b021 61 fields · synced May 18, 2026
- EUDAMED 0a3c74e8-2347-47dc-befb-ae129b8fb02e 61 fields · synced May 18, 2026
- EUDAMED 3984ad80-05c6-45dd-89d6-78a1ba66e137 61 fields · synced May 18, 2026
- EUDAMED 96285cd8-21d6-4165-9dd2-2c8cc40e4502 61 fields · synced May 19, 2026
- EUDAMED 8794e0ee-3d07-47e0-8623-7424a935e6b0 61 fields · synced May 19, 2026