Identity
- Trade Name
- Care bed AURA EUDAMEDFDA UDI
- Generic Name
- Electrical assistive bed FDA UDI
- Device Name
- Malsch elektrische Pflege- und Klinikbetten EUDAMEDThe medical care bed with electric drives is an advanced bed specifically designed for use in medical facilities such as hospitals, nursing homes, and rehabilitation centers. It offers a range of features and characteristics aimed at improving patient comfort, safety, and quality of care. Features and Specifications: Electric Height Adjustment - Adjustable Sleeping Surface - Integrated Side Rails - Integrated Control Unit - Robust Construction. The Care bed AURA provides a safe, comfortable, and functional solution for the care and treatment of patients in medical facilities. It complies with all relevant safety standards and regulations and helps make the caregiving process more efficient and effective. FDA UDI
- Model / Reference
- 000008 EUDAMED1 FDA UDI
- Description
- The medical care bed with electric drives is an advanced bed specifically designed for use in medical facilities such as hospitals, nursing homes, and rehabilitation centers. It offers a range of features and characteristics aimed at improving patient comfort, safety, and quality of care. Features and Specifications: Electric Height Adjustment - Adjustable Sleeping Surface - Integrated Side Rails - Integrated Control Unit - Robust Construction. The Care bed AURA provides a safe, comfortable, and functional solution for the care and treatment of patients in medical facilities. It complies with all relevant safety standards and regulations and helps make the caregiving process more efficient and effective. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04065848000083 EUDAMEDFDA UDI
- Basic UDI-DI
- 4065848MALSCH-PKL00002V EUDAMED
- Direct Marketing DI
- 04065848000083 EUDAMED
- FDA Product Code
- FNL FDA UDI
- EMDN Code
- V08060101 HOSPITAL/HOME CARE ELECTRIC MEDICAL BEDS EUDAMED
- GMDN Term
- Electrical assistive bed FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5100 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Care bed AURA by Malsch 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 | 4065848MALSCH-PKL00002V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Malsch GmbH
- EUDAMED SRN
- DE-MF-000005173
Sources (2)
- EUDAMED a14be68b-f860-48be-bd68-d957b15d53e3 61 fields · synced Jul 9, 2026
- FDA UDI 5eba1af3-8306-41c8-ae60-3974d028f0d8 34 fields · synced May 29, 2026