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Medical aid
EUDAMEDClass I (EU MDR)
Ref FT-6101Model FT-6101/FT-6101C/FT-6100/FT-6100C/FT-6105-A/FT-6105-B/FT-6105-B/FT-6103C/FT-6103S/FT-6104C/FT-6104S
Identity
- Device Name
- Medical aid EUDAMED
- Model / Reference
- FT-6101/FT-6101C/FT-6100/FT-6100C/FT-6105-A/FT-6105-B/FT-6105-B/FT-6103C/FT-6103S/FT-6104C/FT-6104S EUDAMEDFT-6101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975289968003 EUDAMED
- Basic UDI-DI
- 697528996FTMAWV EUDAMED
- EMDN Code
- Y0999 PERSONAL CARE AIDS - 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
Medical aid by Fort Metal Plastic Products (huizhou) co ., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697528996FTMAWV | Class I | Active |
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Manufacturer
- Manufacturer
- Fort Metal Plastic Products (huizhou) co ., Ltd.
- EUDAMED SRN
- CN-MF-000016919
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9c5ba6c6-702b-40f2-899c-59aee00254e8 61 fields · synced Oct 6, 2026