Nord Liner Tt Cushion – Type 2.2 Nf-34
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- NORD LINER TT CUSHION – TYPE 2.2 NF-34 EUDAMEDNord Liner FDA UDI
- Generic Name
- External limb prosthesis socket liner FDA UDI
- Device Name
- NORD LINER TT CUSHION – Available in TYPE 2.1 NF-34, TYPE 2.2 NF-29 and TYPE 2.2 NF-34 EUDAMED
- Model / Reference
- NORD LINER TT CUSHION EUDAMED222202 EUDAMEDNORD LINER 2.2 - NF34 Size M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350128490508 EUDAMEDFDA UDI
- Basic UDI-DI
- 73501284926J EUDAMED
- FDA Product Code
- ISS FDA UDI
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
- GMDN Term
- External limb prosthesis socket liner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Mechanical-resistance external ankle-foot prosthesis
Nord Liner Tt Cushion – Type 2.2 Nf-34 by Nord Ability AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical-resistance external ankle-foot prosthesis.
- TruStep — COLLEGE PARK INDUSTRIES, INC. · Class I
- Iceross Comfort® Locking — Össur Iceland ehf. · Class I
- Tribute — COLLEGE PARK INDUSTRIES, INC. · Class I
- Venture — COLLEGE PARK INDUSTRIES, INC. · Class I
- Aviator — COLLEGE PARK INDUSTRIES, INC. · Class I
- Soleus — COLLEGE PARK INDUSTRIES, INC. · Class I
- Proprio Foot® — Össur Iceland ehf. · Class I
- Onyx — COLLEGE PARK INDUSTRIES, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73501284926J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nord Ability AB
- EUDAMED SRN
- SE-MF-000002255
Sources (2)
- EUDAMED 52f9e7ae-198e-4afa-bfd8-ed302cb85c2c 61 fields · synced Jul 10, 2026
- FDA UDI 32e008e1-6cb8-4b0a-996e-5e2aa022be8d 32 fields · synced May 29, 2026