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Hygia Splint
EUDAMEDClass I (EU MDR)
Ref WS-1011Ref Hygia Belt Splint - WS-1022FRef Hygia Splint - WS-1021Ref Hygia Belt Splint - WS-3053FRef Hygia Belt Splint - WS-1032FRef Hygia Splint - WS.1055Ref Hygia Belt Splint - WS-1021FRef Hygia Splint - WS-1032Ref Hygia Belt Splint - WS-1041FRef Hygia Splint - WS-1051Ref Hygia Belt Splint - WS-3055FRef Hygia Splint - WS-1052Ref Hygia Belt SplintRef Hygia Belt Splint - WS-3053Ref Hygia Splint - WS-1053Ref Hygia Belt Splint - WS.1031FRef Hygia Belt Splint - WS-3051F
Identity
- Trade Name
- Hygia Splint EUDAMED
- Device Name
- HYGIA SPLINT & HYGIA BELT SPLINT EUDAMED
- Model / Reference
- WS-1011 EUDAMEDHygia Belt Splint - WS-1022F EUDAMEDHygia Splint - WS-1021 EUDAMEDHygia Belt Splint - WS-3053F EUDAMEDHygia Belt Splint - WS-1032F EUDAMEDHygia Splint - WS.1055 EUDAMEDHygia Belt Splint - WS-1021F EUDAMEDHygia Splint - WS-1032 EUDAMEDHygia Belt Splint - WS-1041F EUDAMEDHygia Splint - WS-1051 EUDAMEDHygia Belt Splint - WS-3055F EUDAMEDHygia Splint - WS-1052 EUDAMEDHygia Belt Splint EUDAMEDHygia Belt Splint - WS-3053 EUDAMEDHygia Splint - WS-1053 EUDAMEDHygia Belt Splint - WS.1031F EUDAMEDHygia Belt Splint - WS-3051F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8800211WS1011LN EUDAMED138800211WS1022F017 EUDAMED138800211WS1021034 EUDAMED138800211WS3053F003 EUDAMED138800211WS1032F008 EUDAMED138800211WS1055082 EUDAMED138800211WS1021F047 EUDAMED138800211WS1032021 EUDAMED138800211WS1041F029 EUDAMED138800211WS1051025 EUDAMED138800211WS3055F040 EUDAMED138800211WS1052015 EUDAMED138800211WS3051007 EUDAMED138800211WS3053084 EUDAMED138800211WS1053005 EUDAMED138800211WS1031F038 EUDAMED138800211WS3051F063 EUDAMED
- Basic UDI-DI
- 88002111EUSPLX EUDAMED
- Direct Marketing DI
- 8800211WS1011LN EUDAMED138800211WS1022F017 EUDAMED138800211WS1021034 EUDAMED138800211WS3053F003 EUDAMED138800211WS1032F008 EUDAMED138800211WS1055082 EUDAMED138800211WS1021F047 EUDAMED138800211WS1032021 EUDAMED138800211WS1041F029 EUDAMED138800211WS1051025 EUDAMED138800211WS3055F040 EUDAMED138800211WS1052015 EUDAMED138800211WS3051007 EUDAMED138800211WS3053084 EUDAMED138800211WS1053005 EUDAMED138800211WS1031F038 EUDAMED138800211WS3051F063 EUDAMED
- EMDN Code
- Y061219 CHEST-LUMB-SACRAL-HIP-KNEE-ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Hygia Splint by Woosam Medical 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 | 88002111EUSPLX | Class I | Active |
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Manufacturer
- Manufacturer
- Woosam Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000045208
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (17)
- EUDAMED 8d833b3a-056f-4900-88ac-0fe09cd491c3 61 fields · synced Aug 2, 2026
- EUDAMED a54b065e-4396-46a1-b9cb-731c802bc217 61 fields · synced May 16, 2026
- EUDAMED a2fb3675-fede-4c46-9bfd-da4e5f04f2e5 61 fields · synced May 16, 2026
- EUDAMED e5c07fbe-5b63-48d1-9e4d-ffc613a6945b 61 fields · synced May 16, 2026
- EUDAMED 1d67a64e-bad1-4c7f-8cf7-daa18ce9a347 61 fields · synced May 16, 2026
- EUDAMED 9a131feb-1934-4cff-b7ba-1f2673717e68 61 fields · synced May 16, 2026
- EUDAMED 68aec051-ff3e-487c-aa34-0e9b1b87394e 61 fields · synced May 17, 2026
- EUDAMED a1023f49-737f-4adc-849d-93bd4a92ff45 61 fields · synced May 17, 2026
- EUDAMED f951bf7e-c5ec-4d1d-862e-6c07eebaa1f5 61 fields · synced May 17, 2026
- EUDAMED 2a7e8c40-c940-4402-bc7a-9edb5012492a 61 fields · synced May 17, 2026
- EUDAMED eb3f67bf-d278-4166-807b-9e68fbe120d1 61 fields · synced May 17, 2026
- EUDAMED fc4a4869-4c39-4269-9945-b12c00bdb21e 61 fields · synced May 18, 2026
- EUDAMED adcacafb-2b4e-497e-a7e1-e491eae644b7 61 fields · synced May 18, 2026
- EUDAMED efb05608-1ff1-4214-8b7e-2b9088508807 61 fields · synced May 18, 2026
- EUDAMED bc3ce56f-973a-4710-b1ed-98be606e7fc8 61 fields · synced May 19, 2026
- EUDAMED e369f016-be34-4a0a-8a5d-78c05632801a 61 fields · synced May 19, 2026
- EUDAMED c484ef41-e398-46dc-8fb0-98f385530ad8 61 fields · synced May 19, 2026