Identity
- Trade Name
- Integrity V500 EUDAMEDFDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- Integrity V500 EUDAMEDMain handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00627908020024 A82 Amplitrode: DI 00627908020031 A90 VivoAmp: DI 00627908020048 B71W Bone Conductor: DI 00627908020055 ER-2-800 Insert Earphones: DI 00627908020062 ER-3A-800 Insert Earphones: DI 00627908020079 ER-3C-800 Insert Earphones: DI 00627908020086 H-800 EP Headphones: DI 00627908020093 H-801 EP Headphones: DI 00627908020109 P81-GP OAE Probe: DI 00627908020116 P81-UG OAE Probe: DI 00627908020123 Computer: DI 00627908020130 FDA UDI
- Model / Reference
- Integrity V500 EUDAMEDV500 EUDAMEDFDA UDI
- Description
- Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00627908020024 A82 Amplitrode: DI 00627908020031 A90 VivoAmp: DI 00627908020048 B71W Bone Conductor: DI 00627908020055 ER-2-800 Insert Earphones: DI 00627908020062 ER-3A-800 Insert Earphones: DI 00627908020079 ER-3C-800 Insert Earphones: DI 00627908020086 H-800 EP Headphones: DI 00627908020093 H-801 EP Headphones: DI 00627908020109 P81-GP OAE Probe: DI 00627908020116 P81-UG OAE Probe: DI 00627908020123 Computer: DI 00627908020130 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908020017 EUDAMEDFDA UDI
- Basic UDI-DI
- 62790802049R EUDAMED
- Direct Marketing DI
- 00627908020017 EUDAMED
- 510(k) Number
- K043396 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- EMDN Code
- Z12140401,Z129013 EUDAMED
- GMDN Term
- Otoacoustic emission system, battery-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Integrity V500 by Vivosonic Inc — 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 | 62790802049R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Vivosonic, Inc.
- EUDAMED SRN
- CA-MF-000045922
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 215aa750-7060-44b4-9c8f-f439e330d167 61 fields · synced May 31, 2026
- FDA UDI 7cfb0431-4736-42ba-b316-0019cc9acd04 34 fields · synced May 27, 2026