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Garment
EUDAMEDClass I (EU MDR)
Ref FV-21Model 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-15Ref FV-24Ref FV-20Ref WV-14Ref FV-15Ref FV-16Ref WV-20Ref WV-15Ref FV-13
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 EUDAMEDFV-21 EUDAMEDFV-24 EUDAMEDFV-20 EUDAMEDWV-14 EUDAMEDFV-15 EUDAMEDFV-16 EUDAMEDWV-20 EUDAMEDWV-15 EUDAMEDFV-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984060545 EUDAMED06975984060514 EUDAMED06975984060552 EUDAMED06975984060866 EUDAMED06975984060576 EUDAMED06975984060569 EUDAMED06975984060842 EUDAMED06975984060859 EUDAMED06975984060590 EUDAMED
- Basic UDI-DI
- 6970341680112400H3 EUDAMED
- Direct Marketing DI
- 06975984060545 EUDAMED06975984060514 EUDAMED06975984060552 EUDAMED06975984060866 EUDAMED06975984060576 EUDAMED06975984060569 EUDAMED06975984060842 EUDAMED06975984060859 EUDAMED06975984060590 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 (9)
- EUDAMED 1e2b2191-7031-45e9-83f6-73e3712648c8 61 fields · synced Jul 28, 2026
- EUDAMED 8ad1d256-0a04-4197-9c18-3ca23a3f2d3a 61 fields · synced May 17, 2026
- EUDAMED c5b600e2-84ff-43d6-ade4-fa157163bad7 61 fields · synced May 17, 2026
- EUDAMED 084711ae-cfe0-4f98-8c63-323851a5bbd6 61 fields · synced May 18, 2026
- EUDAMED 3ed8b9f3-3baf-4193-95ff-699e3561a33c 61 fields · synced May 18, 2026
- EUDAMED f761146a-36bc-4000-9a2e-4f12c11e6a6b 61 fields · synced May 18, 2026
- EUDAMED 4b720827-086b-4b7e-9ee8-2dbe25c8e31b 61 fields · synced May 18, 2026
- EUDAMED 40d2eb57-c932-45d6-9b02-983c7c8c1a27 61 fields · synced May 19, 2026
- EUDAMED fe6a26d9-f28e-4e27-9a37-9ce6478da774 61 fields · synced May 19, 2026