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Hallufix Hallux valgus Schiene mit Gel-Seitenkissen, Gr. M, 36-42
EUDAMEDClass I (EU MDR)
Ref 60106002
Identity
- Trade Name
- Hallufix Hallux valgus Schiene mit Gel-Seitenkissen, Gr. M, 36-42 EUDAMED
- Device Name
- Hallufix Hallux valgus Schiene EUDAMED
- Model / Reference
- 60106002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260092021116 EUDAMED
- Basic UDI-DI
- 4048792GF010018W EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Orthotic insole, prefabricated, non-antimicrobial
Hallufix Hallux valgus Schiene mit Gel-Seitenkissen, Gr. M, 36-42 by Ludwig Bertram GmbH — 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 | 4048792GF010018W | Class I | Active |
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Manufacturer
- Manufacturer
- Ludwig Bertram GmbH
- EUDAMED SRN
- DE-MF-000013037
Sources (1)
- EUDAMED 92e265bb-05a2-4163-8e8a-c31706eb65ce 61 fields · synced Oct 6, 2026