Identity
- Trade Name
- Endotracheal Balloon Catheter EUDAMEDA-View EUDAMED
- Device Name
- A-View Endotracheal Balloon Catheter EUDAMEDA-View EUDAMED
- Model / Reference
- 01-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720299333802 EUDAMED
- Basic UDI-DI
- 8720299333801-002K5 EUDAMEDB-08720299333802 EUDAMED
- Direct Marketing DI
- 08720299333802 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMEDG0301010101 OESOPHAGEAL BALLOON CATHETERS, LOW PRESSURE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Endotracheal Balloon Catheter by Stroke2Prevent — Class I — MDD, 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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8720299333801-002K5 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8720299333801-002K5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stroke2Prevent
- EUDAMED SRN
- NL-MF-000010912
Sources (2)
- EUDAMED dd5696ae-53bf-40da-938b-94481bd5c3a1 61 fields · synced Jul 9, 2026
- EUDAMED a6d9a494-5ea0-4f46-b7bb-308a2013e51e 61 fields · synced May 18, 2026