← Back to catalogue
Adhesive Wound Dressing
EUDAMEDClass I (EU MDR)
Ref Non-woven fabric/4 in x 4.75 in (10cm x12cm)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) EUDAMEDNon-woven fabric/4 in x 4.75 in (10cm x12cm) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973161441149 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
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
- Gamgee BP – Non-sterile 45x45cm — Robinson Healthcare Ltd · Class I
- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hubei Decen Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000003013
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4547d896-e797-40f3-a5ff-22bd3962f81f 61 fields · synced Jun 19, 2026