Identity
- Trade Name
- Hapla EUDAMED
- Device Name
- Orthotics EUDAMED
- Model / Reference
- Orthotics EUDAMEDBAS011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50126542040818 EUDAMED
- Basic UDI-DI
- 5012654ORT100M2 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Hapla by Cuxson Gerrard & Co. Ltd — Class I — 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 | 5012654ORT100M2 | Class I | Active |
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Manufacturer
- Manufacturer
- Cuxson Gerrard & Co. Ltd
- EUDAMED SRN
- GB-MF-000004499
- Authorised Representative
- Cuxson Gerrard Healthcare Ltd IE-AR-000003838
Sources (1)
- EUDAMED dd955973-eb9b-4c43-b30a-2b89dcc92c42 61 fields · synced Jun 19, 2026