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Nora
EUDAMEDFDA UDIClass I (EU MDR)
Ref K120 BEKA Lifter / Aufstehhilfe und deren ZubehörModel K120 BEKA Lifter und deren Zubehör
Identity
- Trade Name
- NORA EUDAMEDNORA Pro EUDAMEDNora Pro Stand Aid FDA UDI
- Generic Name
- General-purpose patient lifting system sling/harness FDA UDI
- Device Name
- CARLO Alu Classic 185 EUDAMEDStand Aid FDA UDI
- Model / Reference
- K120 BEKA Lifter und deren Zubehör EUDAMEDK120 BEKA Lifter / Aufstehhilfe und deren Zubehör EUDAMED921078000 FDA UDI
- Description
- Stand Aid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260735020308 EUDAMED04260681890222 EUDAMEDFDA UDI
- Basic UDI-DI
- 426068189120BM EUDAMED
- Direct Marketing DI
- 04260735020308 EUDAMED04260681890222 EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- V0805030102 ELECTRIC MOBILE LIFTS EUDAMED
- GMDN Term
- General-purpose patient lifting system sling/harness FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5510 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Nora by BEKA Hospitec GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426068189120BM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BEKA-Hospitec GmbH
- EUDAMED SRN
- DE-MF-000013895
Sources (3)
- EUDAMED 2d6be26f-6307-400a-9cec-d13f18b8de03 61 fields · synced Jul 22, 2026
- EUDAMED 42eb1397-7d04-4a36-a26c-af315d0fb15b 61 fields · synced May 19, 2026
- FDA UDI f8e127e1-851a-400e-8fb9-8d93da960528 33 fields · synced May 24, 2026