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Spacer Fabric Heel Support
EUDAMEDClass I (EU MDR)
Ref Heel-OS-11Model Orthopedic Supports -1
Identity
- Trade Name
- Spacer Fabric Heel Support EUDAMED
- Device Name
- Ankle support/Wrist splint/knee support/thumb support EUDAMED
- Model / Reference
- Orthopedic Supports -1 EUDAMEDHeel-OS-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00732240910213 EUDAMED
- Basic UDI-DI
- 007322409OLDERXY EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Spacer Fabric Heel Support by Irufa Industrial Group CO., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 007322409OLDERXY | Class I | Active |
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Manufacturer
- Manufacturer
- Irufa Industrial Group CO., LTD.
- EUDAMED SRN
- TW-MF-000046083
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED e83d7c44-f499-4d22-acd5-80c6ab416bbe 61 fields · synced Jul 19, 2026