Identity
- Trade Name
- Ergozone 5000 FDA UDI
- Generic Name
- Basic bed mattress FDA UDI
- Device Name
- The passive mattres is the foam mattress intended for medical bed. FDA UDI
- Model / Reference
- EZ5-EMCX FDA UDI
- Description
- The passive mattres is the foam mattress intended for medical bed. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08592654851043 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Basic bed mattress FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Basic bed mattress
Ergozone 5000 by L I N E T spol. s r.o. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- L I N E T spol. s r.o.
Sources (1)
- FDA UDI 78ca65b8-9edc-420b-8216-1d7a3445fe5e 33 fields · synced May 30, 2026