Identity
- Trade Name
- Hapla EUDAMED
- Device Name
- Adhesive & Non-Adhesive Paddings & Strappings EUDAMED
- Model / Reference
- TOF131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05012654205552 EUDAMED
- Basic UDI-DI
- 5012654PAD100C4 EUDAMED
- EMDN Code
- M03030203 FOAM PADS 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 | 5012654PAD100C4 | 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 4bed60f0-a7f0-4631-ba5a-881cf94faa9d 61 fields · synced Jun 18, 2026