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Adhesive Wound Dressing
EUDAMEDClass I (EU MDR)
Ref Polyurethane/3.15 in x 4 in (8cm x10cm)Model Model: Polyurethane,Non-woven fabric. Specifications: 1.56 in x1.56in(4cm x 4cm), 2.36 in x 2.75in(6cmx 7cm), 3.15 in x 4 in (8cm x10cm),4 in x 4.75 in (10cm x12cm),4in x 6in (10cm x 15cm), 4in x 10in (10cm x 25cm), 6 in x 8 in (15cm x 20cm)
Identity
- Device Name
- Adhesive Wound Dressing EUDAMED
- Model / Reference
- Model: Polyurethane,Non-woven fabric. Specifications: 1.56 in x1.56in(4cm x 4cm), 2.36 in x 2.75in(6cmx 7cm), 3.15 in x 4 in (8cm x10cm),4 in x 4.75 in (10cm x12cm),4in x 6in (10cm x 15cm), 4in x 10in (10cm x 25cm), 6 in x 8 in (15cm x 20cm) EUDAMEDPolyurethane/3.15 in x 4 in (8cm x10cm) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973161441064 EUDAMED
- Basic UDI-DI
- 697316144AWD01DN EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Adhesive Wound Dressing by Hubei Decen Biotechnology Co., 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 | 697316144AWD01DN | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Decen Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000003013
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b63ccf40-9aed-4a58-a7b5-8148edc7a8ac 61 fields · synced Jun 18, 2026