← Back to catalogue

Hybernite RT 2000 (Dual Limb)

EUDAMED

Class IIa (EU MDR)

Ref HEN15040BT1SSWGKModel 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

by Plastiflex Group NV

Identity

Trade Name
Hybernite RT 2000 (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 EUDAMED
HEN15040BT1SSWGK EUDAMED

Identifiers

Primary DI / UDI-DI
05404013003594 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

Hybernite RT 2000 (Dual Limb) by Plastiflex Group NV — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Plastiflex Group NV
EUDAMED SRN
BE-MF-000008049

Sources (1)

  • EUDAMED 089ba26c-db40-4104-aa62-a18a8b930e80 61 fields · synced Jul 31, 2026