Identity
- Trade Name
- Fubupore EUDAMED
- Device Name
- Adhesive Wound Dressings EUDAMED
- Model / Reference
- 82201~82249 EUDAMED82215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716819821519 EUDAMED
- Basic UDI-DI
- 047168198822BW EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
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
Fubupore by Modern Healthcare Corp. — 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 | 047168198822BW | Class I | Active |
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Manufacturer
- Manufacturer
- Modern Healthcare Corp.
- EUDAMED SRN
- TW-MF-000013668
- Authorised Representative
- Euregio Business Center BE-AR-000009949
Sources (1)
- EUDAMED 5a31ae2f-fc9a-4923-9c6f-e40c576d3486 61 fields · synced Jun 18, 2026