← Back to catalogue
Reusable Standard Iso/Sevo Adapter
EUDAMEDClass I (EU MDR)
Ref 26064Model Reusable Abbvie QuikFil® Adapter
Identity
- Trade Name
- Reusable Standard Iso/Sevo Adapter EUDAMED
- Device Name
- Adapter EUDAMED
- Model / Reference
- Reusable Abbvie QuikFil® Adapter EUDAMED26064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391530290098 EUDAMED
- Basic UDI-DI
- 539153029026002FG EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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: Pulmonary function analysis system, adult
Reusable Standard Iso/Sevo Adapter by Sedana Medical Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function analysis system, adult.
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- VISCOFLU — PHARMA LINE Srl · Class IIb
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
Manufacturer's product page: Single-Use Standard Iso/Sevo Adapter
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 539153029026002FG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sedana Medical Limited
- EUDAMED SRN
- IE-MF-000001734
Sources (1)
- EUDAMED 2c4eaa95-3fe6-404f-96cb-dde2928aa86f 61 fields · synced Jun 19, 2026