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Nord Liner Tt Cushion – Type 2.1 Nf-34

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 212228Model NORD LINER TT CUSHION

by Nord Ability AB

Identity

Trade Name
NORD LINER TT CUSHION – TYPE 2.1 NF-34 EUDAMED
Nord 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 EUDAMED
212228 EUDAMED
NORD LINER 2.1 - NF34 Size 28 FDA UDI

Identifiers

Primary DI / UDI-DI
07350128490447 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

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

No

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

No

FDA UDI

Category: Mechanical-resistance external ankle-foot prosthesis

Nord Liner Tt Cushion – Type 2.1 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nord Ability AB
EUDAMED SRN
SE-MF-000002255

Sources (2)

  • EUDAMED 198645a9-4824-4008-855d-d132c729d70f 61 fields · synced Jun 18, 2026
  • FDA UDI 749c4522-606c-40d8-b343-9b10e6f847f1 32 fields · synced May 30, 2026