Identity
- Trade Name
- Tom 2 EUDAMEDFDA UDI
- Generic Name
- Paediatric bed FDA UDI
- Device Name
- Hospital/Home Care Pediatric Electric Medical Beds EUDAMEDPediatric hospital bed. FDA UDI
- Model / Reference
- 1K40B511-586 EUDAMED1K41B511-10 FDA UDI
- Description
- Pediatric hospital bed. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08592654598184 EUDAMED08592654348000 FDA UDI
- Basic UDI-DI
- 8592654370100AU EUDAMED
- FDA Product Code
- FMS FDA UDI
- EMDN Code
- V0806010701 HOSPITAL/HOME CARE PEDIATRIC ELECTRIC MEDICAL BEDS EUDAMED
- GMDN Term
- Paediatric bed FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5140 FDA UDI
- Market of Registration
- Czechia 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
Category: Paediatric bed
Tom 2 by L I N E T spol. s r.o. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- L I N E T spol. s r.o.
Sources (2)
- FDA UDI b0e34ffd-3675-43f4-b4ab-892e7e5db115 33 fields · synced Jul 14, 2026
- EUDAMED bcd24a28-a1a2-4bf8-b16d-f6d7a01eb6d4 61 fields · synced Jul 14, 2026