Identity
- Device Name
- CUSTOM PACK FOR NON-INVASIVE VENTILATION EUDAMED
- Model / Reference
- CP1217M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323067820 EUDAMED
- Basic UDI-DI
- 80583230DCUSTOMRD EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Custom Pack For Non-Invasive Ventilation by Intersurgical SpA — Class IIa — 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
- 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
- Demand Valve, 3M Hose - AGA (NORDIC) Probe — BNOS MediTECH · Class IIa
- MGC Diagnostics — MEDICAL GRAPHICS CORP. · Class I
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 | 80583230DCUSTOMRD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intersurgical SpA
- EUDAMED SRN
- IT-MF-000010729
Sources (1)
- EUDAMED 27fe88e6-8ae7-46ef-be5e-c61def8cdcab 61 fields · synced Jul 29, 2026