Identity
- Trade Name
- Anaesthesia screen EUDAMEDFDA UDI
- Generic Name
- Anaesthesia screen FDA UDI
- Device Name
- Accessory EUDAMED
- Model / Reference
- 90321 EUDAMEDrigid FDA UDI
Identifiers
- Catalog Number
- 90321 FDA UDI
- Primary DI / UDI-DI
- 07640143932610 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014393Accessories45 EUDAMED
- FDA Product Code
- GDC FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Anaesthesia screen FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function analysis system, adult
Anaesthesia screen by Schaerer Medical Ag — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764014393Accessories45 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Schaerer Medical AG
- EUDAMED SRN
- CH-MF-000038078
- Authorised Representative
- Intelleg Management GmbH DE-AR-000037613
Sources (2)
- EUDAMED f519c0bd-0200-4be9-be3f-9c4a3bb307fa 61 fields · synced Jul 9, 2026
- FDA UDI ef0026ba-20b2-4590-9562-8dd9468922d0 33 fields · synced May 30, 2026