Identity
- Trade Name
- SequaFilm EUDAMED
- Device Name
- Polyurethane film dressings EUDAMED
- Model / Reference
- many EUDAMEDSQ131012Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931132220032 EUDAMED
- Basic UDI-DI
- 693113223419B3 EUDAMED
- Direct Marketing DI
- 06931132220032 EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
SequaFilm by Foshan United Medical Technologies Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 693113223419B3 | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan United Medical Technologies Ltd.
- EUDAMED SRN
- CN-MF-000017922
- Authorised Representative
- Medwheat Tech Service GmbH DE-AR-000006844
Sources (1)
- EUDAMED c4563390-1ec5-4ea0-b264-c9729f1c9257 61 fields · synced Aug 4, 2026