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Ankle Support
EUDAMEDClass I (EU MDR)
Ref 1008-BG-M-1Ref 2001-BG-M-1Ref 1001-BG-XL-1Ref 1001-BK-L-1Ref RA200-BK-S-1Ref 1008-BG-S-1Ref 1004-BG-L-1Ref 2900-GY-M-1Ref 2001-BG-XL-1Ref 2004-BG-S-1Ref RA200-BK-XL-1Ref 1008-BK-XL-1Ref 2001-BG-S-1Ref 2900-GY-L-1Ref 4007-BG-M-1Ref 1001-BK-M-1Ref RA200-BK-M-1Ref 1008-BK-L-1Ref 1008-BK-M-1Ref 2502-BG-XL-1Ref 4007-BG-S-1Ref 2004-BG-XL-1Ref 2502-BG-M-1Ref 4007-BG-L-1Ref 2502-BG-S-1Ref 1001-BK-XL-1Ref 1004-BG-M-1Ref 1201-BG-M-1
Identity
- Trade Name
- Ankle Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 1008-BG-M-1 EUDAMED2001-BG-M-1 EUDAMED1001-BG-XL-1 EUDAMED1001-BK-L-1 EUDAMEDRA200-BK-S-1 EUDAMED1008-BG-S-1 EUDAMED1004-BG-L-1 EUDAMED2900-GY-M-1 EUDAMED2001-BG-XL-1 EUDAMED2004-BG-S-1 EUDAMEDRA200-BK-XL-1 EUDAMED1008-BK-XL-1 EUDAMED2001-BG-S-1 EUDAMED2900-GY-L-1 EUDAMED4007-BG-M-1 EUDAMED1001-BK-M-1 EUDAMEDRA200-BK-M-1 EUDAMED1008-BK-L-1 EUDAMED1008-BK-M-1 EUDAMED2502-BG-XL-1 EUDAMED4007-BG-S-1 EUDAMED2004-BG-XL-1 EUDAMED2502-BG-M-1 EUDAMED4007-BG-L-1 EUDAMED2502-BG-S-1 EUDAMED1001-BK-XL-1 EUDAMED1004-BG-M-1 EUDAMED1201-BG-M-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863690186 EUDAMED04719863691053 EUDAMED04719863690049 EUDAMED04719863694818 EUDAMED04713375500261 EUDAMED04719863690179 EUDAMED04719863690155 EUDAMED04711769153475 EUDAMED04719863691077 EUDAMED04719863696744 EUDAMED04713375500292 EUDAMED04711769140857 EUDAMED04719863691046 EUDAMED04711769153482 EUDAMED04719863692708 EUDAMED04719863694795 EUDAMED04713375500278 EUDAMED04711769140840 EUDAMED04711769140833 EUDAMED04719863699141 EUDAMED04719863692692 EUDAMED04719863696775 EUDAMED04719863699127 EUDAMED04719863692715 EUDAMED04719863699110 EUDAMED04719863699103 EUDAMED04719863690148 EUDAMED04719863697116 EUDAMED
- Basic UDI-DI
- 471986369CL102DF EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER 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
Yes
EUDAMEDEUDAMED
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
Ankle Support by OPPO Medical Corp. — 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 | 471986369CL102DF | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (28)
- EUDAMED 384dfc45-a062-4d59-942e-41a6d733082a 61 fields · synced Aug 3, 2026
- EUDAMED e922c413-fa57-4f5e-9a5e-5ed54c6b2cc5 61 fields · synced May 11, 2026
- EUDAMED 5293667e-e7cb-46f8-b7ea-0aae5c0f063a 61 fields · synced May 16, 2026
- EUDAMED 70b14c03-d025-47d0-9354-b6a0f6cce77f 61 fields · synced May 16, 2026
- EUDAMED b696720b-ef00-4a84-a09b-2db41e0d5252 61 fields · synced May 16, 2026
- EUDAMED 319b8548-da3d-4e08-a8be-2c5e1e58688e 61 fields · synced May 16, 2026
- EUDAMED 26a5617c-e8ee-43f7-806e-87ccd46da380 61 fields · synced May 16, 2026
- EUDAMED 7e7d23c4-5881-4857-b9f8-0455922aabd3 61 fields · synced May 16, 2026
- EUDAMED 7a298ca5-c62b-42b1-a8e4-c11c736ff1df 61 fields · synced May 16, 2026
- EUDAMED 3b06d41d-1d40-4d01-9ab7-540d8b70a6fe 61 fields · synced May 17, 2026
- EUDAMED d6cdbce7-e742-4604-9393-b139daec616b 61 fields · synced May 17, 2026
- EUDAMED 0605d718-e317-4a06-9875-87099d565dfa 61 fields · synced May 17, 2026
- EUDAMED 6ee19c2c-c1f0-4955-b54f-da5552b45120 61 fields · synced May 17, 2026
- EUDAMED 888924cc-332c-4a34-8e2c-41e9ad20f92e 61 fields · synced May 17, 2026
- EUDAMED 71afc277-561e-4851-ad6c-6583e06ed44e 61 fields · synced May 17, 2026
- EUDAMED 135b0414-59a8-47a4-99b9-bacfd49ed348 61 fields · synced May 18, 2026
- EUDAMED 40b65a3e-c4fe-4451-b571-26bc52928764 61 fields · synced May 18, 2026
- EUDAMED d2fc64c3-f430-406e-820d-84b70897302d 61 fields · synced May 18, 2026
- EUDAMED 58b5bcbc-4c43-44a4-bb92-6da6ec93960b 61 fields · synced May 18, 2026
- EUDAMED 48f99294-f68c-4450-abf2-5095596443b6 61 fields · synced May 18, 2026
- EUDAMED 8d8c010d-8b62-4044-beb8-46570b20536f 61 fields · synced May 18, 2026
- EUDAMED d6f6aa02-ae00-4bc0-894d-b6b8b3cc2812 61 fields · synced May 18, 2026
- EUDAMED afbad35a-3c32-4c54-9793-5031b00486a1 61 fields · synced May 18, 2026
- EUDAMED d2805949-84d9-4fae-953a-6044c24d6356 61 fields · synced May 18, 2026
- EUDAMED 5d9b4116-b944-43f0-abe8-ed266321ecf8 61 fields · synced May 18, 2026
- EUDAMED c920ec44-16b6-49de-9cff-4b0e8906374f 61 fields · synced May 19, 2026
- EUDAMED b7b9fa0b-3c11-4625-832f-33c4d7ec09bf 61 fields · synced May 19, 2026
- EUDAMED 013a4b9a-5ca0-420d-9745-ac1db991727a 61 fields · synced May 19, 2026