Nord Sleeve - Type 1.2 Nf-34
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- NORD SLEEVE - TYPE 1.2 NF-34 EUDAMEDNord Sleeve FDA UDI
- Generic Name
- External limb prosthesis socket liner FDA UDI
- Device Name
- NORD SLEEVE – Available in TYPE 1.1 NF-29 and TYPE 1.2 NF-34 EUDAMEDNord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users limb and prosthetic socket thus creating suspension through vacuum. FDA UDI
- Model / Reference
- NORD SLEEVE EUDAMED122202 EUDAMEDNORD SLEEVE 1.2 - NF34 Size 2 FDA UDI
- Description
- Nord Sleeve-Prosthetic sleeve to assist by keeping an air tight environment between the users limb and prosthetic socket thus creating suspension through vacuum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350128490331 EUDAMEDFDA UDI
- Basic UDI-DI
- 73501284916G 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 Sleeve - Type 1.2 Nf-34 by Nord Ability AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73501284916G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nord Ability AB
- EUDAMED SRN
- SE-MF-000002255
Sources (2)
- EUDAMED 49f2efa3-aab6-4461-ba11-9473cf12fbc2 61 fields · synced Jul 9, 2026
- FDA UDI 0641709a-b091-4e80-a38d-e26e21c6434a 33 fields · synced May 30, 2026