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312g
EUDAMEDClass I (EU MDR)
Ref 67DSSPRef TACARef INVSCBRRef HG314Ref INVSCFP1PRef GFPCARef INVSCLPRef GHSBRef GFPCSRef LHCRef INVSCHR
Identity
- Device Name
- 312G EUDAMED
- Model / Reference
- 67DSSP EUDAMEDTACA EUDAMEDINVSCBR EUDAMEDHG314 EUDAMEDINVSCFP1P EUDAMEDGFPCA EUDAMEDINVSCLP EUDAMEDGHSB EUDAMEDGFPCS EUDAMEDLHC EUDAMEDINVSCHR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060937941406 EUDAMED05060937940027 EUDAMED05060937940072 EUDAMED05060937941604 EUDAMED05060937940041 EUDAMED05060937941130 EUDAMED05060937940058 EUDAMED05060937941338 EUDAMED05060937941147 EUDAMED05060937941154 EUDAMED05060937940065 EUDAMED
- Basic UDI-DI
- 506093794312G2P EUDAMED
- EMDN Code
- Y122499 WHEELCHAIRS ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
312g by Gel Ovations Europe Limited — 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 | 506093794312G2P | Class I | Active |
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Manufacturer
- Manufacturer
- Gel Ovations Europe Limited
- EUDAMED SRN
- GB-MF-000024690
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (11)
- EUDAMED 96ef297a-d047-45e9-8ef7-3248faa05a81 61 fields · synced Oct 6, 2026
- EUDAMED 1f5f863a-b34b-4f89-a00f-1c16f695752d 61 fields · synced May 16, 2026
- EUDAMED 024cfe92-e864-496e-9da7-ac2f5c6acf31 61 fields · synced May 16, 2026
- EUDAMED 3e0e2acf-6de0-4cbb-a715-a16112af54ca 61 fields · synced May 16, 2026
- EUDAMED 9d8052c5-b70a-4544-9bcf-af7282003250 61 fields · synced May 17, 2026
- EUDAMED 1f2b7359-d7a7-4509-9a44-55a25151a85a 61 fields · synced May 17, 2026
- EUDAMED 79e7468b-8321-4e8b-a05c-86d035c17f5f 61 fields · synced May 17, 2026
- EUDAMED 58f44906-607d-434b-be7a-d769371f14a1 61 fields · synced May 18, 2026
- EUDAMED 8a15c7ab-dedf-4cd3-b77a-c5769f7ad2b1 61 fields · synced May 18, 2026
- EUDAMED 7ec3f531-c7eb-4708-b183-daa0b9ad9c63 61 fields · synced May 18, 2026
- EUDAMED c8342b76-8498-419f-81c3-8bb08bab6c49 61 fields · synced May 18, 2026