Identity
- Trade Name
- Zerostat Spacer EUDAMED
- Device Name
- Zerostat Spacer EUDAMED
- Model / Reference
- Not Applicable for Zerostat Spacer EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8901117ZSP0123YGAA EUDAMED
- Basic UDI-DI
- B-8901117ZSP0123YGAA 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 Spacer by Cipla Limited — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-8901117ZSP0123YGAA | Class I | No Longer Active |
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Manufacturer
- Manufacturer
- Cipla Limited
- EUDAMED SRN
- IN-MF-000038939
- Authorised Representative
- Cipla Europe NV BE-AR-000038918
Sources (1)
- EUDAMED 8eb5c136-024b-409f-9fed-e5a754ebbccb 61 fields · synced Jun 18, 2026