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Sc 5010 Sek
EUDAMEDFDA UDIClass I (EU MDR)
Ref 288.000000Model Mobile Operating Tables
Identity
- Trade Name
- SC 5010 SEK EUDAMEDAKRUS FDA UDI
- Generic Name
- General examination/treatment chair, electric FDA UDI
- Device Name
- Mobile Surgical Chairs and Beds EUDAMED
- Model / Reference
- Mobile Operating Tables EUDAMED288.000000 EUDAMEDSC 5010SEK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260647941562 EUDAMEDFDA UDI
- Basic UDI-DI
- 426064794SC5010SEKL8 EUDAMED
- Direct Marketing DI
- 04260647941562 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Z12011201 OPERATING CHAIRS EUDAMED
- GMDN Term
- General examination/treatment chair, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sc 5010 Sek by AKRUS GmbH & Co. KG — 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 | 426064794SC5010SEKL8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AKRUS GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005262
Sources (2)
- EUDAMED e7e0a62c-3ca8-46b0-beb0-c4333e38c47b 61 fields · synced Jun 19, 2026
- FDA UDI 01a8d3a4-7ada-4af9-b293-e788e3d6538e 32 fields · synced May 30, 2026