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Gel Ovations Europe
EUDAMEDClass I (EU MDR)
Ref 38SFP2218Ref 18SFP0404Ref 18SFP0506Ref 18SFP1010Ref 2020BCBRef 410GWTRef 58SFP2020Ref 12SFP1212Ref GSP141010Ref DP2SC10Ref 775DRef 12SFP1816Ref SRHR15Ref SRAFSRef LDCNSRef 57UESRef 14SFP2420Ref 58SFP0404Ref 7PFPCSRef HG74Ref 14SFP0707Ref 514SRHRef 316TMSRef SSFCD118Ref 18SFP1212Ref 18SFP1818Ref 3125DRef 3185DRef RFROSMRef TA0462-SRef DGTPRef 895DRef SRASGRef SRFSMBSRef SAB3C1Ref TM0066Ref CDRSRef 89SRSSGRef KSBRef SRFSMBERef 18SFP2420Ref SSF118RSRef 28205DRef MCH4Ref PF215Ref SSF120GBRef OTLMRef 38SFP1010Ref MFCZRef 1616BCTBRef 685D
Identity
- Trade Name
- GEL OVATIONS EUROPE EUDAMED
- Device Name
- GEL FILLED CUSHION EUDAMED312G EUDAMEDWALKING AIDS EUDAMED
- Model / Reference
- 38SFP2218 EUDAMED18SFP0404 EUDAMED18SFP0506 EUDAMED18SFP1010 EUDAMED2020BCB EUDAMED410GWT EUDAMED58SFP2020 EUDAMED12SFP1212 EUDAMEDGSP141010 EUDAMEDDP2SC10 EUDAMED775D EUDAMED12SFP1816 EUDAMEDSRHR15 EUDAMEDSRAFS EUDAMEDLDCNS EUDAMED57UES EUDAMED14SFP2420 EUDAMED58SFP0404 EUDAMED7PFPCS EUDAMEDHG74 EUDAMED14SFP0707 EUDAMED514SRH EUDAMED316TMS EUDAMEDSSFCD118 EUDAMED18SFP1212 EUDAMED18SFP1818 EUDAMED3125D EUDAMED3185D EUDAMEDRFROSM EUDAMEDTA0462-S EUDAMEDDGTP EUDAMED895D EUDAMEDSRASG EUDAMEDSRFSMBS EUDAMEDSAB3C1 EUDAMEDTM0066 EUDAMEDCDRS EUDAMED89SRSSG EUDAMEDKSB EUDAMEDSRFSMBE EUDAMED18SFP2420 EUDAMEDSSF118RS EUDAMED28205D EUDAMEDMCH4 EUDAMEDPF215 EUDAMEDSSF120GB EUDAMEDOTLM EUDAMED38SFP1010 EUDAMEDMFCZ EUDAMED1616BCTB EUDAMED685D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060937940775 EUDAMED05060937940485 EUDAMED05060937940492 EUDAMED05060937940539 EUDAMED05060937945442 EUDAMED05060937942182 EUDAMED05060937941086 EUDAMED05060937940867 EUDAMED05060937942922 EUDAMED05060937942755 EUDAMED05060937940393 EUDAMED05060937940898 EUDAMED05060937943455 EUDAMED05060937943301 EUDAMED05060937940300 EUDAMED05060937941789 EUDAMED05060937943158 EUDAMED05060937940966 EUDAMED05060937942830 EUDAMED05060937945602 EUDAMED05060937940669 EUDAMED05060937944742 EUDAMED05060937942137 EUDAMED05060937944384 EUDAMED05060937940546 EUDAMED05060937940584 EUDAMED05060937940430 EUDAMED05060937940461 EUDAMED05060937944575 EUDAMED05060937945299 EUDAMED05060937943400 EUDAMED05060937940379 EUDAMED05060937945121 EUDAMED05060937942458 EUDAMED05060937941734 EUDAMED05060937945343 EUDAMED05060937945510 EUDAMED05060937945206 EUDAMED05060937943806 EUDAMED05060937944230 EUDAMED05060937940638 EUDAMED05060937944353 EUDAMED05060937940287 EUDAMED05060937944476 EUDAMED05060937942342 EUDAMED05060937944339 EUDAMED05060937942380 EUDAMED05060937943219 EUDAMED05060937944469 EUDAMED05060937944605 EUDAMED05060937944117 EUDAMED
- Basic UDI-DI
- 506093794DIMJA EUDAMED506093794312G2P EUDAMED506093794WKUK 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
Gel Ovations Europe by Gel Ovations Europe Limited — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506093794DIMJA | Class I | Active |
| EUDAMED | European Union | CE/MDD | 506093794DIMJA | 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 (51)
- EUDAMED 018ab160-0d9d-4365-9cc1-62e1cf2929a9 61 fields · synced Oct 6, 2026
- EUDAMED 29ef67c0-d7ec-4824-bab7-44d7807fe2c8 61 fields · synced May 11, 2026
- EUDAMED 5a74ef38-b843-4603-8991-ab5d65ffb814 61 fields · synced May 11, 2026
- EUDAMED 6d81230a-dc4b-4d52-b215-37b8ceaedcb5 61 fields · synced May 11, 2026
- EUDAMED c63d571b-f6f5-44ca-8fe5-87db212ad8b1 61 fields · synced May 11, 2026
- EUDAMED e3c2e9b7-f1cd-4316-a068-28b4b1a6a744 61 fields · synced May 11, 2026
- EUDAMED e7c8507a-9cf9-4bf5-960c-b6690a22fc3a 61 fields · synced May 11, 2026
- EUDAMED 03e730af-e47e-4ed3-b3ec-493340a2a499 61 fields · synced May 11, 2026
- EUDAMED 10754845-8b34-47f3-9065-f74f6b2913f2 61 fields · synced May 11, 2026
- EUDAMED 41bcfbcb-ed1d-40bc-a9d2-2dc90d47dab3 61 fields · synced May 16, 2026
- EUDAMED 932c957d-7f44-4a49-98ba-1cb225c03f72 61 fields · synced May 16, 2026
- EUDAMED 2f3bfee2-931c-4e8d-ab9b-916f41d828b9 61 fields · synced May 16, 2026
- EUDAMED 648d9ecc-9eda-489b-9d34-0f29e1382a8b 61 fields · synced May 16, 2026
- EUDAMED 79280e82-2bef-46a9-82d2-63b1cb1b6545 61 fields · synced May 16, 2026
- EUDAMED d53021e8-015d-457c-890c-7aa119e5c611 61 fields · synced May 16, 2026
- EUDAMED 761bd2ff-155e-46f0-b639-d5e07a36d587 61 fields · synced May 16, 2026
- EUDAMED c6dbe399-b7df-4ad3-9129-3139761cdf63 61 fields · synced May 16, 2026
- EUDAMED cc8f6ce3-b4e5-4f81-b777-b7b6886c9e37 61 fields · synced May 16, 2026
- EUDAMED d08396e9-0a9c-4a1c-a732-7b94e96768e2 61 fields · synced May 16, 2026
- EUDAMED 2da584db-3906-4664-837a-6fa4631ab825 61 fields · synced May 16, 2026
- EUDAMED 4df61e7f-4c34-4d6f-9243-4a3550ba6c4a 61 fields · synced May 16, 2026
- EUDAMED d6d23608-1dc7-484e-812f-7c01fcc9fd4a 61 fields · synced May 16, 2026
- EUDAMED 7c562e36-7c57-43f6-a95c-71851cfae355 61 fields · synced May 16, 2026
- EUDAMED 3b06d24c-04b6-44c1-862e-c4bb5fe36b9c 61 fields · synced May 16, 2026
- EUDAMED 8e57a652-35b5-4dc8-88e7-90c7dab85d0c 61 fields · synced May 16, 2026
- EUDAMED ef5c239d-2a9c-4b9c-b38d-d8f46ca9dffc 61 fields · synced May 16, 2026
- EUDAMED 2d222e11-81da-4eb2-91da-180e186231a2 61 fields · synced May 16, 2026
- EUDAMED 33385e82-80c2-44da-9010-8bf4e3ec464a 61 fields · synced May 16, 2026
- EUDAMED c31da336-8557-482f-b789-d5d58899c2ba 61 fields · synced May 16, 2026
- EUDAMED c2285d7c-1f12-475f-b0d1-3e326531a910 61 fields · synced May 16, 2026
- EUDAMED 0453578e-5917-4534-b599-432bf5593ac1 61 fields · synced May 16, 2026
- EUDAMED bf677d0e-5470-4184-97bd-2752b188a363 61 fields · synced May 16, 2026
- EUDAMED 0cdada11-e87d-4a34-9124-dc6a335bad83 61 fields · synced May 16, 2026
- EUDAMED b4933d0a-7a64-4a07-b920-93fd4437b1da 61 fields · synced May 16, 2026
- EUDAMED 1534d376-d94f-4de4-9520-6703fe540341 61 fields · synced May 16, 2026
- EUDAMED 2e5d6930-40c8-4daf-8978-ff64e7e61ae4 61 fields · synced May 16, 2026
- EUDAMED ec88bae6-2122-4b0b-90c8-95ed1111544f 61 fields · synced May 16, 2026
- EUDAMED fef962cf-0bd3-4dac-8938-fb246a0595ff 61 fields · synced May 16, 2026
- EUDAMED b874dee8-1c81-4916-be9b-09730569585c 61 fields · synced May 16, 2026
- EUDAMED 6d39bd87-048c-43ec-9509-538ff7469a52 61 fields · synced May 16, 2026
- EUDAMED 252ba5d8-358e-4a88-b8cc-28b1725d2d05 61 fields · synced May 17, 2026
- EUDAMED d6a849ef-4bfb-49b1-b9dd-3ee19aa7bb6b 61 fields · synced May 17, 2026
- EUDAMED 42ec5f08-7885-45ef-88f1-a9ab917c8946 61 fields · synced May 17, 2026
- EUDAMED 71cbb22f-f33d-48e2-9d6e-14f2c2d664aa 61 fields · synced May 17, 2026
- EUDAMED 925abae2-ff88-401a-b427-b003c257c030 61 fields · synced May 17, 2026
- EUDAMED a60f0580-2967-4031-856e-9c6c68beee25 61 fields · synced May 17, 2026
- EUDAMED 05434a8e-b955-41e0-8709-c46641d156f0 61 fields · synced May 17, 2026
- EUDAMED bc631af1-dff0-47b1-9c71-344ddd411690 61 fields · synced May 17, 2026
- EUDAMED eac50c55-2ad5-4ef8-a06d-833b0d8f0287 61 fields · synced May 17, 2026
- EUDAMED 101cb6c9-3eb4-4c6a-af32-20a0bc8a3001 61 fields · synced May 17, 2026
- EUDAMED e046a324-4c4a-4ea5-a3de-8eaabbb94506 61 fields · synced May 17, 2026