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Elastic Bandage
EUDAMEDClass I (EU MDR)
Ref KT-AA-02Model Kinesiology Tape：Synthetic Series (Pre-cut) KT-AA-02，KT-AB-02，KT-AC-02 Ref UT-AD-02Model Kinesiology Tape：Cotton Series (Standard, Roll) UT-AA-02，UT-AB-02, UT-AC-02, UT-AD-02 Ref KT-AC-02Ref UT-AA-02
by Fashlon Inc.
Identity
- Device Name
- Elastic Bandage EUDAMED
- Model / Reference
- Kinesiology Tape：Synthetic Series (Pre-cut) KT-AA-02，KT-AB-02，KT-AC-02 EUDAMEDKT-AA-02 EUDAMEDKinesiology Tape：Cotton Series (Standard, Roll) UT-AA-02，UT-AB-02, UT-AC-02, UT-AD-02 EUDAMEDUT-AD-02 EUDAMEDKT-AC-02 EUDAMEDUT-AA-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00627949247008 EUDAMED00627949247060 EUDAMED00627949247022 EUDAMED00627949247039 EUDAMED
- Basic UDI-DI
- 0627949247Ktape-synt2Q EUDAMED0627949247Ktape-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-synt2Q | 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 (4)
- EUDAMED 7f8f02c6-38a7-4953-b892-b4bc9ee7005d 61 fields · synced Jul 12, 2026
- EUDAMED 5ba84f9a-214a-44e1-a29f-e1c8ffef8989 61 fields · synced May 18, 2026
- EUDAMED 2107ac65-ab47-41c2-a984-c9e9755b60c3 61 fields · synced May 18, 2026
- EUDAMED 84b4c9b0-8e48-4705-91fb-cf16f3d4c832 61 fields · synced May 19, 2026