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Hema
EUDAMEDClass IIa (EU MDR)
Ref HE-0818584Model 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
by Aso Llc
Identity
- Trade Name
- HEMA EUDAMED
- Device Name
- Non-Sterile Hydrocolloid Bandages EUDAMED
- Model / Reference
- 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 EUDAMEDHE-0818584 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721245263846 EUDAMED
- Basic UDI-DI
- 0017276M226M3 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
Hema 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 | 0017276M226M3 | 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 (1)
- EUDAMED 9a3e09d9-de88-4317-a75c-2c0c76eba45c 61 fields · synced Aug 1, 2026