Identity
- Trade Name
- Accessory Box AB-08 EUDAMEDAccessory Box AB08 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Ear Tips for Ear Probes EUDAMEDAccessory box Content: 1. Box. AN101329 2. Ear Tip PM007H 7 mm mushroom. AN100765-PH 3. Ear Tip PM009H 9 mm mushroom. AN100767-PH 4. Ear Tip PM010H 10 mm mushroom. AN100768-PH 5. Ear Tip PM011H 11 mm mushroom. AN100769-PH 6. Ear Tip PM012H 12 mm mushroom. AN100770-PH 7. Ear Tip PM013H 13 mm mushroom. AN100771-PH 8. Ear Tip PM014H 14 mm mushroom. AN100772-PH 9. Ear Tip PM016H 16 mm mushroom. AN100773-PH 10. Ear Tip PM018H 18 mm mushroom. AN100774-PH FDA UDI
- Model / Reference
- 100734-P EUDAMEDFDA UDI
- Description
- Accessory box Content: 1. Box. AN101329 2. Ear Tip PM007H 7 mm mushroom. AN100765-PH 3. Ear Tip PM009H 9 mm mushroom. AN100767-PH 4. Ear Tip PM010H 10 mm mushroom. AN100768-PH 5. Ear Tip PM011H 11 mm mushroom. AN100769-PH 6. Ear Tip PM012H 12 mm mushroom. AN100770-PH 7. Ear Tip PM013H 13 mm mushroom. AN100771-PH 8. Ear Tip PM014H 14 mm mushroom. AN100772-PH 9. Ear Tip PM016H 16 mm mushroom. AN100773-PH 10. Ear Tip PM018H 18 mm mushroom. AN100774-PH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223146138 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022Probes-16B EUDAMED
- FDA Product Code
- GWJ FDA UDI
- EMDN Code
- Z12140380,Z12149001 EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class I 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
Yes
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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
Accessory Box AB08 by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
- ECochG Adapters — Vivosonic Inc · Class II
- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
- TEOAE probe tips — Otodynamics · Class II
- ABR Case service kit - Top — Otodynamics · Class II
- Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
- ABR Test Cavity — Otodynamics · Class II
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 3886c452-ee25-427b-8898-3a86a4cc1b70 33 fields · synced Jul 21, 2026
- EUDAMED 3525dfcc-94f1-40f2-9892-70e46cec6e29 61 fields · synced Jul 21, 2026