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Heka
EUDAMEDClass IIa (EU MDR)
Ref VH-OT0172Model 40-3004 / 781229Ref VH-OT0181Model 40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378 Ref VH-OT0198Ref VH-OT0176Ref VH-OT0174
by Aso Llc
Identity
- Trade Name
- HEKA EUDAMED
- Device Name
- Non-Sterile Hydrocolloid Bandages EUDAMED
- Model / Reference
- 40-3004 / 781229 EUDAMEDVH-OT0172 EUDAMED40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378 EUDAMEDVH-OT0181 EUDAMEDVH-OT0198 EUDAMEDVH-OT0176 EUDAMEDVH-OT0174 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886028759 EUDAMED08715886028728 EUDAMED08715886028872 EUDAMED08715886028810 EUDAMED08715886028780 EUDAMED
- Basic UDI-DI
- 0017276M424M9 EUDAMED0017276M226M3 EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Heka by Aso LLC — Class IIa — 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 | 0017276M424M9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aso Llc
- EUDAMED SRN
- US-MF-000008641
- Authorised Representative
- Aso Europe BV NL-AR-000004377
Sources (5)
- EUDAMED a53e51e5-4193-41c6-b832-22cf93293b3b 61 fields · synced Jul 21, 2026
- EUDAMED 6e13e657-a69f-4f4f-9849-56f779160470 61 fields · synced Jun 14, 2026
- EUDAMED 698bd88f-5be7-46f9-888c-24c5bf8a7e89 61 fields · synced Jun 18, 2026
- EUDAMED 5fb67464-d7d5-43c6-ae41-0c01a1646de1 61 fields · synced Jul 13, 2026
- EUDAMED c958c53e-6301-4fe5-9dc7-21b2150e53f0 61 fields · synced Jul 21, 2026