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Flexible Waterproof Bandages

EUDAMED

Class I (EU MDR)

Ref polyurethane/0.75 in x 3 in (19mm x76mm)Model polyurethane/16mm x 57mm, polyurethane/19mm x 57mm, polyurethane/19mm x72mm, polyurethane/25mm x 76mm, polyurethane/38mm x 38mm, polyurethane/51mm x 76mm, polyurethane/51mm x 102mm,polyethylene/19mm x72mm,polyethylene/25mm x 76mmRef polyethylene/0.75 in x 2.83 in (19mm x72mm)Ref polyurethane/0.625 in x 2.25 in (16mm x 57mm)Ref polyurethane/2 in x 4 in (51mm x 102mm)Ref polyurethane/0.75 in x 2.83 in (19mm x72mm)Ref non-woven fabric/0.75 in x 2.25in (19mm x 57mm)Ref polyurethane/1.5 in x 1.5 in (38mm x 38mm)Ref polyurethane/19mm x 57mm /19mm x72mm /25mm x 76mm /38mm x 38mm /51mm x 76mmRef polyurethane/2 in x 3 in (51mm x 76mm)Ref non-woven fabric/0.75 in x 3 in (19mm x76mm)

by Hubei Decen Biotechnology Co., Ltd

Identity

Device Name
Flexible Waterproof Bandages EUDAMED
Model / Reference
polyurethane/16mm x 57mm, polyurethane/19mm x 57mm, polyurethane/19mm x72mm, polyurethane/25mm x 76mm, polyurethane/38mm x 38mm, polyurethane/51mm x 76mm, polyurethane/51mm x 102mm,polyethylene/19mm x72mm,polyethylene/25mm x 76mm EUDAMED
polyurethane/0.75 in x 3 in (19mm x76mm) EUDAMED
polyethylene/0.75 in x 2.83 in (19mm x72mm) EUDAMED
polyurethane/0.625 in x 2.25 in (16mm x 57mm) EUDAMED
polyurethane/2 in x 4 in (51mm x 102mm) EUDAMED
polyurethane/0.75 in x 2.83 in (19mm x72mm) EUDAMED
non-woven fabric/0.75 in x 2.25in (19mm x 57mm) EUDAMED
polyurethane/1.5 in x 1.5 in (38mm x 38mm) EUDAMED
polyurethane/19mm x 57mm /19mm x72mm /25mm x 76mm /38mm x 38mm /51mm x 76mm EUDAMED
polyurethane/2 in x 3 in (51mm x 76mm) EUDAMED
non-woven fabric/0.75 in x 3 in (19mm x76mm) EUDAMED

Identifiers

Primary DI / UDI-DI
06973161440029 EUDAMED
06973161440043 EUDAMED
06973161440005 EUDAMED
06973161440074 EUDAMED
06973161440081 EUDAMED
06973161441019 EUDAMED
06973161440050 EUDAMED
06973161440272 EUDAMED
06973161440067 EUDAMED
06973161441026 EUDAMED
Basic UDI-DI
697316144FWB01F3 EUDAMED
EMDN Code
M03030299 PROTECTION SYSTEMS - 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

EUDAMEDEUDAMED

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: Cast/bandage waterproof bathing cover, reusable

Flexible Waterproof Bandages by Hubei Decen Biotechnology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Cast/bandage waterproof bathing cover, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 (10)

  • EUDAMED b608a054-e45c-4b0f-85b8-d17f0bcb112f 61 fields · synced Aug 4, 2026
  • EUDAMED 0aff5961-b1de-4d6f-b380-d08b89a36152 61 fields · synced May 16, 2026
  • EUDAMED 66ab42cc-2b7c-4a41-86fc-5cb80b8b72a5 61 fields · synced May 16, 2026
  • EUDAMED e66dc0ab-b0a8-4e7f-a611-1438c0c74f0d 61 fields · synced May 17, 2026
  • EUDAMED 11c525ca-4389-4396-b1b6-a421f2aa64bd 61 fields · synced May 17, 2026
  • EUDAMED 4e4091cb-5a0e-4c6f-9755-a5093a2e82c1 61 fields · synced May 17, 2026
  • EUDAMED 276fb3eb-7660-4d37-8013-d4161fbd45af 61 fields · synced May 18, 2026
  • EUDAMED 6a22d293-cd04-49f0-8fc4-7225ddb0c7f5 61 fields · synced May 18, 2026
  • EUDAMED 7936b4dc-0541-4905-954e-011661e495ff 61 fields · synced May 19, 2026
  • EUDAMED 800b2b5f-1207-4964-b4f7-8f4d8df08439 61 fields · synced May 19, 2026