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Elastic Bandage
EUDAMEDClass I (EU MDR)
Ref UT-AC-02Model Kinesiology Tape：Cotton Series (Standard, Roll) UT-AA-02，UT-AB-02, UT-AC-02, UT-AD-02
by Fashlon Inc.
Identity
- Device Name
- Elastic Bandage EUDAMED
- Model / Reference
- Kinesiology Tape：Cotton Series (Standard, Roll) UT-AA-02，UT-AB-02, UT-AC-02, UT-AD-02 EUDAMEDUT-AC-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00627949247053 EUDAMED
- Basic UDI-DI
- 0627949247Ktape-cottW5 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
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: Cast/bandage waterproof bathing cover, reusable
Elastic Bandage by Fashlon Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cast/bandage waterproof bathing cover, reusable.
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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 | 0627949247Ktape-cottW5 | Class I | Active |
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Manufacturer
- Manufacturer
- Fashlon Inc.
- EUDAMED SRN
- CA-MF-000052116
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 09f3393d-425b-44d3-854e-755933488c38 61 fields · synced Jun 19, 2026