Identity
- Trade Name
- Lábujjpárna lábujjfixálóval L-bal EUDAMED
- Device Name
- Kalapácsujj korrigáló EUDAMED
- Model / Reference
- 508154/002/652 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049261008307 EUDAMED
- Basic UDI-DI
- 4049261KBL EUDAMED
- Direct Marketing DI
- 04049261008307 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
Yes
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
Lábujjpárna lábujjfixálóval L-bal by Berkemann Hungary Bt. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 4049261KBL | Class I | Active |
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Manufacturer
- Manufacturer
- Berkemann Hungary Bt.
- EUDAMED SRN
- HU-MF-000007044
Sources (1)
- EUDAMED 61bce7b8-c877-4628-a609-b3b12f1b0c5c 61 fields · synced Jul 25, 2026