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ALGO 7i ABR Cable long
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 101002Model ABR-LRef 101049Model A7i-101049
Identity
- Trade Name
- ALGO 7i EUDAMEDFDA UDIALGO 7i Patient Cable long FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- ALGO 7i ABR Cable long EUDAMEDALGO 7i EUDAMEDALGO 7i Patient Cable 72 Inch FDA UDIALGO 7i Newborn Hearing Screener FDA UDI
- Model / Reference
- ABR-L EUDAMED101002 EUDAMEDFDA UDI101049 EUDAMEDFDA UDIA7i-101049 EUDAMED
- Description
- ALGO 7i Patient Cable 72 Inch FDA UDIALGO 7i Newborn Hearing Screener FDA UDI
Identifiers
- Catalog Number
- A7i-101002 FDA UDIA7i-101049 FDA UDI
- Primary DI / UDI-DI
- 04260223145490 EUDAMEDFDA UDI04260223145414 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022ALGO7i-1EC EUDAMED0426022ALGO7i-2aLU EUDAMED
- Direct Marketing DI
- 04260223145490 EUDAMED
- 510(k) Number
- K211147 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- EMDN Code
- Z12140380 EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDZ12140302 EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI
- Market of Registration
- Ireland EUDAMEDGermany 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
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
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ALGO 7i ABR Cable long by PATH medical GmbH — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211147 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0426022ALGO7i-1EC | Class I | Active |
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Manufacturer
- Manufacturer
- PATH MEDICAL GmbH
- EUDAMED SRN
- DE-MF-000006935
Sources (5)
- EUDAMED f7f7f3d4-e405-42f3-99b0-76365dc09bd7 61 fields · synced Jul 12, 2026
- FDA UDI f6bffd78-2128-4b9e-bdf7-5f313bae067d 35 fields · synced May 30, 2026
- FDA UDI fb9d108e-849c-4378-aa19-635d1be136e9 35 fields · synced May 30, 2026
- EUDAMED 3372b363-d72b-4e75-b5e3-e8d772b00130 61 fields · synced Jul 12, 2026
- FDA 510(k) K211147 1 fields · synced May 18, 2026