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Hybernite RT 3000 (Dual Limb)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref HEN12041BT1PRWGKModel The Hybernite RT breathing tubes are combined in breathing sets in a single limb version (only inspiratory tube) or a dual limb (inspiratory and expiratory tube) version. Products are available in 3 diameters and in different packaging combinations
Identity
- Trade Name
- Hybernite RT 3000 (Dual Limb) EUDAMED
- Device Name
- Hybernite RT EUDAMED
- Model / Reference
- The Hybernite RT breathing tubes are combined in breathing sets in a single limb version (only inspiratory tube) or a dual limb (inspiratory and expiratory tube) version. Products are available in 3 diameters and in different packaging combinations EUDAMEDHEN12041BT1PRWGK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404013003587 EUDAMED
- Basic UDI-DI
- 5404013000000000000026B EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Ventilator breathing circuit, single-use
Hybernite RT 3000 (Dual Limb) by Plastiflex Group NV — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151461 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5404013000000000000026B | Class IIa | Active |
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Manufacturer
- Manufacturer
- Plastiflex Group NV
- EUDAMED SRN
- BE-MF-000008049
Sources (2)
- EUDAMED 88ba7ac9-fd3c-45a6-a02e-4244f8e595fd 61 fields · synced Jul 14, 2026
- FDA 510(k) K151461 1 fields · synced May 18, 2026