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Sacro Lumbar Support
EUDAMEDClass I (EU MDR)
Ref 2264-12-BG-S-1Ref 2164-BG-XXL-1Ref 2164-BG-M-1Ref 2065-12-BK-M-1Ref 2164-BG-L-1Ref 1064-BG-XL-1Ref 2065-9-BG-XL-1Ref 2164-BG-XL-1Ref 2267-6-BG-M-1Ref 2065-9-BG-XXXL-1Ref 2065-12-BG-M-1Ref 2065-12-BG-L-1Ref 2065-12-BG-XL-1Ref 2267-10-BG-XL-1Ref 2068-BG-M-1Ref 2163-13-BG-XXL-1Ref 2163-13-BG-XL-1Ref 2168-BG-L-1Ref 2264-12-BG-XXXL-1Ref 2267-10-BG-L-1Ref 2065-9-BG-M-1Ref 2068-BG-S-1Ref 2264-12-BG-M-1Ref 2163-13-BG-M-1Ref 2163-15-BG-XXL-1Ref 2168-BG-S-1Ref 2065-9-BG-XXL-1Ref 2065-12-BG-S-1Ref 1064-BG-L-1Ref 2164-BG-XXXL-1Ref 2267-10-BG-S-1Ref 2065-9-BK-S-1Ref 2065-12-BG-XXL-1Ref 2065-9-BK-XXL-1Ref 2265-BG-XXL-1Ref 2163-15-BG-M-1Ref 2265-BG-L-1Ref 2065-9-BK-XXXL-1Ref 2265-BG-M-1Ref 2264-9-BG-XL-1Ref 2163-13-BG-S-1Ref 2163-15-BG-S-1Ref 2163-13-BG-L-1
Identity
- Trade Name
- Sacro Lumbar Support EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2264-12-BG-S-1 EUDAMED2164-BG-XXL-1 EUDAMED2164-BG-M-1 EUDAMED2065-12-BK-M-1 EUDAMED2164-BG-L-1 EUDAMED1064-BG-XL-1 EUDAMED2065-9-BG-XL-1 EUDAMED2164-BG-XL-1 EUDAMED2267-6-BG-M-1 EUDAMED2065-9-BG-XXXL-1 EUDAMED2065-12-BG-M-1 EUDAMED2065-12-BG-L-1 EUDAMED2065-12-BG-XL-1 EUDAMED2267-10-BG-XL-1 EUDAMED2068-BG-M-1 EUDAMED2163-13-BG-XXL-1 EUDAMED2163-13-BG-XL-1 EUDAMED2168-BG-L-1 EUDAMED2264-12-BG-XXXL-1 EUDAMED2267-10-BG-L-1 EUDAMED2065-9-BG-M-1 EUDAMED2068-BG-S-1 EUDAMED2264-12-BG-M-1 EUDAMED2163-13-BG-M-1 EUDAMED2163-15-BG-XXL-1 EUDAMED2168-BG-S-1 EUDAMED2065-9-BG-XXL-1 EUDAMED2065-12-BG-S-1 EUDAMED1064-BG-L-1 EUDAMED2164-BG-XXXL-1 EUDAMED2267-10-BG-S-1 EUDAMED2065-9-BK-S-1 EUDAMED2065-12-BG-XXL-1 EUDAMED2065-9-BK-XXL-1 EUDAMED2265-BG-XXL-1 EUDAMED2163-15-BG-M-1 EUDAMED2265-BG-L-1 EUDAMED2065-9-BK-XXXL-1 EUDAMED2265-BG-M-1 EUDAMED2264-9-BG-XL-1 EUDAMED2163-13-BG-S-1 EUDAMED2163-15-BG-S-1 EUDAMED2163-13-BG-L-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863691862 EUDAMED04719863691657 EUDAMED04719863691626 EUDAMED04713375501084 EUDAMED04719863691633 EUDAMED04719863690643 EUDAMED04719863691947 EUDAMED04719863691640 EUDAMED04711769147306 EUDAMED04711769153963 EUDAMED04719863691978 EUDAMED04719863691985 EUDAMED04719863691992 EUDAMED04711769147405 EUDAMED04719863694078 EUDAMED04719863696881 EUDAMED04719863696874 EUDAMED04719863697475 EUDAMED04711769141557 EUDAMED04711769147399 EUDAMED04719863691923 EUDAMED04719863694061 EUDAMED04719863691879 EUDAMED04719863696850 EUDAMED04719863696935 EUDAMED04719863697451 EUDAMED04719863691954 EUDAMED04719863691961 EUDAMED04719863690636 EUDAMED04711769144565 EUDAMED04711769147375 EUDAMED04713375501121 EUDAMED04719863692005 EUDAMED04713375501169 EUDAMED04719863698977 EUDAMED04719863696904 EUDAMED04719863694474 EUDAMED04713375501176 EUDAMED04719863694467 EUDAMED04719863691848 EUDAMED04719863696843 EUDAMED04719863696898 EUDAMED04719863696867 EUDAMED
- Basic UDI-DI
- 471986369CL104DK EUDAMED
- EMDN Code
- Y060399 SPINE 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
Sacro Lumbar 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 | 471986369CL104DK | 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 (43)
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