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ALGO 7i ATA Cable long
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 101004Model A7i-101049
Identity
- Trade Name
- ATA-L EUDAMEDALGO 7i ATA Cable long FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- ALGO 7i EUDAMEDALGO 7i ATA Cable 72 inch FDA UDI
- Model / Reference
- 101004 EUDAMEDFDA UDIA7i-101049 EUDAMED
- Description
- ALGO 7i ATA Cable 72 inch FDA UDI
Identifiers
- Catalog Number
- A7i-101004 FDA UDI
- Primary DI / UDI-DI
- 04260223145476 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022ALGO7i-2aLU EUDAMED
- 510(k) Number
- K211147 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- EMDN Code
- Z12140302 EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 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
Yes
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
Category: Evoked-potential audiometer
ALGO 7i ATA Cable long by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K211147 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (2)
- FDA UDI aa3fc781-c37d-461c-b835-dfb439c0c397 35 fields · synced Jul 8, 2026
- EUDAMED 35db345c-1ebf-4ced-bcc6-90f2c1528190 61 fields · synced Jul 8, 2026