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NORA Alu / NORA Alu low
EUDAMEDFDA UDIClass I (EU MDR)
Ref K120 BEKA Lifter / Aufstehhilfe und deren ZubehörModel K120 BEKA Lifter und deren Zubehör
Identity
- Trade Name
- NORA Alu / NORA Alu low EUDAMEDNora ALU 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 EUDAMED921074008 FDA UDI
- Description
- Stand Aid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260735020346 EUDAMEDFDA UDI04260735020292 EUDAMED04260735020353 EUDAMED04260735020360 EUDAMED
- Basic UDI-DI
- 426068189120BM EUDAMED
- Direct Marketing DI
- 04260735020346 EUDAMED04260735020292 EUDAMED04260735020353 EUDAMED04260735020360 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 Alu / NORA Alu low 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 (5)
- EUDAMED 4ebc0fad-f32b-434a-91e0-a84cab0ccd1b 61 fields · synced Jul 21, 2026
- EUDAMED bb0dfcfa-dc34-4a3b-9aed-f9f84043294c 61 fields · synced May 17, 2026
- EUDAMED dd00cd7a-e205-4c3b-8f8c-c2618aa079f9 61 fields · synced May 17, 2026
- EUDAMED fd249ff8-d377-4923-81d8-5e55f3cc9627 61 fields · synced May 19, 2026
- FDA UDI 439a0cd8-8d00-4b9e-9c87-52d8378563c2 33 fields · synced May 30, 2026