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Hybernite
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref HPE15018KT0030GIModel Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff
Identity
- Trade Name
- S.Box HEATED TUBE EUDAMEDHybernite FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Active non implantable respiratory devices. EUDAMED
- Model / Reference
- Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff EUDAMEDHPE15018KT0030GI EUDAMEDSleepbox Heated Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05404013000982 EUDAMEDFDA UDI
- Basic UDI-DI
- 54040130000000000000169 EUDAMED
- FDA Product Code
- BZE FDA UDI
- EMDN Code
- R02010401 CPAP CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5270 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hybernite by Plastiflex Group NV — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- Plastiflex Group NV
Sources (2)
- FDA UDI cc0e23be-bef3-49c4-b4a9-78aecd14bc98 33 fields · synced Jun 18, 2026
- EUDAMED 1cc835b3-810a-41f2-8086-2c4e6982127e 61 fields · synced Jun 18, 2026