← Back to catalogue
Zerostat V Spacer
EUDAMEDClass I (EU MDR)
Ref Not applicable for Zerostat V spacer
Identity
- Trade Name
- Zerostat V Spacer EUDAMED
- Device Name
- Zerostat V Spacer EUDAMED
- Model / Reference
- Not applicable for Zerostat V spacer EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8901117ZEV0123UU5N EUDAMED
- Basic UDI-DI
- B-8901117ZEV0123UU5N EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Zerostat V Spacer by Cipla Limited — Class I — MDD — 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European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-8901117ZEV0123UU5N | Class I | No Longer Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cipla Limited
- EUDAMED SRN
- IN-MF-000038939
- Authorised Representative
- Cipla Europe NV BE-AR-000038918
Sources (1)
- EUDAMED b983bf46-7bf4-4598-8b7c-3121cc530bea 61 fields · synced Jun 18, 2026