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Medicare
EUDAMEDClass IIa (EU MDR)
Ref FLM-MD187 V.6 ECOModel 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 FLM-MD188 V.6 ECORef MD1835Ref FLM-MD1835 V.5 ECOModel 188962 / 18-3362
by Aso Llc
Identity
- Trade Name
- Medicare EUDAMEDMedicare Nasal Strips EUDAMED
- Device Name
- Non-Sterile Hydrocolloid Bandages EUDAMEDPlaster EUDAMEDNasal Dilator Triple Bridge Tan P2S 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 EUDAMEDFLM-MD187 V.6 ECO EUDAMEDFLM-MD188 V.6 ECO EUDAMEDMD1835 EUDAMED188962 / 18-3362 EUDAMEDFLM-MD1835 V.5 ECO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05099390413052 EUDAMED05099390409666 EUDAMED05099390415209 EUDAMED
- Basic UDI-DI
- 0017276M226M3 EUDAMED5099390plasterSL EUDAMED0017276188962S4 EUDAMED
- Unit of Use DI
- 35099390415200 EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMEDM03030202 SKIN PROTECTIVE BANDAGES EUDAMEDM0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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
Medicare 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 (4)
- EUDAMED 5c790c3b-e4b1-435d-8ccb-8d58f43d4f95 61 fields · synced Jul 30, 2026
- EUDAMED 8fa3dcae-5236-4af9-885a-a1f482cc4b7a 61 fields · synced May 19, 2026
- EUDAMED 24c6dbe1-9910-4635-9b90-15b287487e81 61 fields · synced May 19, 2026
- EUDAMED 439c2337-a4a2-4cd4-9814-1bb79cf494a2 61 fields · synced Jul 24, 2026