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Adhesive Wound Dressing
EUDAMEDClass I (EU MDR)
Ref Non-woven fabric/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)Ref Non-woven fabric/2.36 in x 2.75in(6cmx 7cm)Ref Polyurethane/ 6 in x 8 in (15cm x 20cm)Ref Non-woven fabric/4in x 10in (10cm x 25cm)Ref Polyurethane/4in x 6in (10cm x 15cm)Ref Non-woven fabric/1.56 in x1.56in(4cm x 4cm)Ref Polyurethane/1.56 in x1.56in(4cm x 4cm)Ref Polyurethane/4in x 10in (10cm x 25cm)Ref Non-woven fabric/ 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) EUDAMEDNon-woven fabric/3.15 in x 4 in (8cm x10cm) EUDAMEDNon-woven fabric/2.36 in x 2.75in(6cmx 7cm) EUDAMEDPolyurethane/ 6 in x 8 in (15cm x 20cm) EUDAMEDNon-woven fabric/4in x 10in (10cm x 25cm) EUDAMEDPolyurethane/4in x 6in (10cm x 15cm) EUDAMEDNon-woven fabric/1.56 in x1.56in(4cm x 4cm) EUDAMEDPolyurethane/1.56 in x1.56in(4cm x 4cm) EUDAMEDPolyurethane/4in x 10in (10cm x 25cm) EUDAMEDNon-woven fabric/ 6 in x 8 in (15cm x 20cm) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973161441132 EUDAMED06973161441125 EUDAMED06973161441101 EUDAMED06973161441163 EUDAMED06973161441088 EUDAMED06973161441118 EUDAMED06973161441040 EUDAMED06973161441095 EUDAMED06973161441170 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 (9)
- EUDAMED 3292930c-0d3b-4e5e-9c6d-fe5ba51e724a 61 fields · synced Aug 4, 2026
- EUDAMED bf7e7242-20a5-4914-bd03-acb29306f656 61 fields · synced May 17, 2026
- EUDAMED e53d6065-be87-4fc7-ab8a-b27d345ea134 61 fields · synced May 17, 2026
- EUDAMED 0814ae38-b6f7-4d8a-8041-30504cbd40d3 61 fields · synced May 18, 2026
- EUDAMED f93584ef-e401-442d-a592-d300e72c470d 61 fields · synced May 18, 2026
- EUDAMED 59067208-b9ca-4792-986c-05d1f2f1d46e 61 fields · synced May 18, 2026
- EUDAMED de77816e-6112-455c-8750-5c10934bb792 61 fields · synced May 18, 2026
- EUDAMED 7cabf4f5-5cea-4a9a-bbd2-c90f949e9a79 61 fields · synced May 19, 2026
- EUDAMED ffda263a-c7cd-4915-9ea2-b7ddd84dbdc4 61 fields · synced May 19, 2026