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Ankle Brace
EUDAMEDClass I (EU MDR)
Ref 2201-BG-XL-1Ref 2201-BG-L-1Ref 2201-BG-S-1Ref 2103-BG-L-1Ref 2003-BG-M-1Ref 2003-BG-XL-1Ref 2204-BG-M-1Ref 2201-BG-M-1Ref 2204-BG-L-1Ref 2103-BG-M-1Ref 2204-BG-XL-1
Identity
- Trade Name
- Ankle Brace EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2201-BG-XL-1 EUDAMED2201-BG-L-1 EUDAMED2201-BG-S-1 EUDAMED2103-BG-L-1 EUDAMED2003-BG-M-1 EUDAMED2003-BG-XL-1 EUDAMED2204-BG-M-1 EUDAMED2201-BG-M-1 EUDAMED2204-BG-L-1 EUDAMED2103-BG-M-1 EUDAMED2204-BG-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863691114 EUDAMED04719863691107 EUDAMED04719863691084 EUDAMED04719863696393 EUDAMED04719863691145 EUDAMED04719863691169 EUDAMED04719863693958 EUDAMED04719863691091 EUDAMED04719863693965 EUDAMED04719863696386 EUDAMED04711769145982 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
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
Ankle Brace 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 (11)
- EUDAMED 6b4a39da-7170-430d-b00c-709d78f686b0 61 fields · synced Aug 3, 2026
- EUDAMED e385357c-1989-471d-9119-83990074b0cb 61 fields · synced May 11, 2026
- EUDAMED 68787feb-046b-4790-bb6f-00106a13ac95 61 fields · synced May 16, 2026
- EUDAMED d9fd0258-bffe-4bb0-a4a4-bf0ea43e4b15 61 fields · synced May 17, 2026
- EUDAMED f16367d0-f6b3-4af3-abae-a5993f34b124 61 fields · synced May 17, 2026
- EUDAMED 6e2b0c9d-a33b-4974-9fa2-f20ec3147962 61 fields · synced May 18, 2026
- EUDAMED bea88190-dad4-4ddb-821d-677e6a245448 61 fields · synced May 18, 2026
- EUDAMED be0cd503-9c99-4064-9b61-3ba3c4621436 61 fields · synced May 18, 2026
- EUDAMED 8a1ab62f-7ed9-4c0d-bf01-60f1d85809d1 61 fields · synced May 19, 2026
- EUDAMED a9e4f8f8-bbc2-4730-a4af-89f3fbe853e4 61 fields · synced May 19, 2026
- EUDAMED 62c662e8-2407-4e05-b0fb-dc7d3ef0d2ff 61 fields · synced May 19, 2026