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POD Active Knee Brace (Singles)
EUDAMEDFDA UDIClass I (EU MDR)
Ref K8 2.0 (Singles)
Identity
- Trade Name
- POD Active Knee Brace FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- POD Active Knee Brace (Singles) EUDAMEDPOD Active Knee Brace; model K8; version 2.0; single (LT or RT) FDA UDI
- Model / Reference
- K8 2.0 (Singles) EUDAMEDK8 2.0 FDA UDI
- Description
- POD Active Knee Brace; model K8; version 2.0; single (LT or RT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09344006000802 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09344006000802 EUDAMED
- FDA Product Code
- ITQ FDA UDI
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
- GMDN Term
- Knee support orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
POD Active Knee Brace (Singles) by Pod Active Pty Ltd — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09344006000802 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- POD Active Pty Ltd
- EUDAMED SRN
- AU-MF-000003989
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 3307a429-ea5b-474f-9449-84ea43f2f2b3 61 fields · synced Jun 19, 2026
- FDA UDI cace3553-211a-4084-9085-934f60c1e2e6 35 fields · synced May 30, 2026