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Bunion Shield with Loop
EUDAMEDClass I (EU MDR)
Ref MTS0004 (S/M/UNI/WH)Model Toe Separator SeriesRef MTS0004 (L/XL/UNI/WH)
Identity
- Trade Name
- Bunion Shield with Loop EUDAMED
- Device Name
- Toe separator EUDAMED
- Model / Reference
- Toe Separator Series EUDAMEDMTS0004 (S/M/UNI/WH) EUDAMEDMTS0004 (L/XL/UNI/WH) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710374232360 EUDAMED04710374232377 EUDAMED
- Basic UDI-DI
- 471230298TSS9 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Orthotic insole, prefabricated, non-antimicrobial
Bunion Shield with Loop by e-life International Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471230298TSS9 | Class I | Active |
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Manufacturer
- Manufacturer
- e-life International Co., Ltd.
- EUDAMED SRN
- TW-MF-000009901
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 8d000133-e5d7-4d71-845b-80c4bf7f0372 61 fields · synced Jul 22, 2026
- EUDAMED 40bf0df4-0669-4f6b-b26e-dc1d15ead38a 61 fields · synced May 19, 2026