Identity
- Trade Name
- VitaloROV FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- 9100 VITALOGRAPH VitaloROV (En) FDA UDI
- Model / Reference
- 9100 EUDAMEDFDA UDI91910 EUDAMED
- Description
- 9100 VITALOGRAPH VitaloROV (En) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05099169919105 EUDAMEDFDA UDI
- Basic UDI-DI
- 50991699100U3 EUDAMED
- 510(k) Number
- K221030 FDA UDI
- FDA Product Code
- BTY FDA UDI
- EMDN Code
- Z12159003 DIFFUSION ANALYSIS EQUIPMENT EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1890 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
Yes
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
No
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
VitaloROV by Vitalograph Ireland, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K221030 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vitalograph Ireland, Ltd.
Sources (2)
- FDA UDI 09326999-976a-413c-b8f3-51c01aefaebd 34 fields · synced Jul 24, 2026
- EUDAMED 5c8b60c6-5104-4bfb-b575-dd7e59991d9c 61 fields · synced Jun 10, 2026