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Garment
EUDAMEDClass I (EU MDR)
Ref WV-11Model FV-20，FV-21，FV-22，FV-23，FV-24，FV-25，FV-26，WV-20，WV-21，WV-22，WV-23，WV-24，WV-25，FV-10，FV-11，FV-12，FV-13，FV-14，FV-15，FV-16，WV-10，WV-11，WV-12，WV-13，WV-14，WV-15
Identity
- Trade Name
- Garment EUDAMED
- Device Name
- Garment EUDAMED
- Model / Reference
- FV-20，FV-21，FV-22，FV-23，FV-24，FV-25，FV-26，WV-20，WV-21，WV-22，WV-23，WV-24，WV-25，FV-10，FV-11，FV-12，FV-13，FV-14，FV-15，FV-16，WV-10，WV-11，WV-12，WV-13，WV-14，WV-15 EUDAMEDWV-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984060897 EUDAMED
- Basic UDI-DI
- 6970341680112400H3 EUDAMED
- Direct Marketing DI
- 06975984060897 EUDAMED
- EMDN Code
- Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Garment by Shenzhen Lifotronic Technology 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 | 6970341680112400H3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3599fb63-e798-4976-bc8e-eea37320d736 61 fields · synced Jun 18, 2026