Identity
- Trade Name
- VitaloQUB FDA UDI
- Generic Name
- Whole-body plethysmograph FDA UDI
- Device Name
- 9160 VITALOGRAPH VitaloQUB - EN FDA UDI
- Model / Reference
- 9160 EUDAMEDFDA UDI91610 EUDAMED9100 EUDAMED91510 EUDAMED
- Description
- 9160 VITALOGRAPH VitaloQUB - EN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05099169916104 EUDAMEDFDA UDI05099169332157 EUDAMED
- Basic UDI-DI
- 50991699160UM EUDAMED50991699100U3 EUDAMED
- 510(k) Number
- K223818 FDA UDI
- FDA Product Code
- JEH FDA UDI
- EMDN Code
- Z12159007 BODY PLETHYSMOGRAPHS EUDAMEDZ12159003 DIFFUSION ANALYSIS EQUIPMENT EUDAMED
- GMDN Term
- Whole-body plethysmograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1760 FDA UDI
- Market of Registration
- Ireland 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
EUDAMEDEUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
91610 by Vitalograph (ireland) Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 50991699160UM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Vitalograph (Ireland) Limited
- EUDAMED SRN
- IE-MF-000004858
Sources (3)
- EUDAMED 28059349-a0e9-4850-8cb5-b25bacafdf85 61 fields · synced Jul 22, 2026
- FDA UDI f200cd76-dfeb-48c2-b57f-dfeb025999f5 34 fields · synced May 30, 2026
- EUDAMED 443dc2f1-d20d-498c-b954-0797246b60d1 61 fields · synced Jul 12, 2026