Identity
- Trade Name
- DRUM EUDAMEDFDA UDI
- Generic Name
- Hearing aid tester, electrical FDA UDI
- Device Name
- Drum EUDAMEDDrum is a hearing instrument test box (HIT), with a high ambient noise attenuation level, capable of performing all the tests aimed at hearing aids analysis via air conduction. FDA UDI
- Model / Reference
- DRUM EUDAMEDFDA UDI11239 EUDAMED
- Description
- Drum is a hearing instrument test box (HIT), with a high ambient noise attenuation level, capable of performing all the tests aimed at hearing aids analysis via air conduction. FDA UDI
Identifiers
- Catalog Number
- 11239 FDA UDI
- Primary DI / UDI-DI
- 08054187380730 EUDAMEDFDA UDI
- Basic UDI-DI
- 805418738HT1LE EUDAMED
- FDA Product Code
- ETW FDA UDI
- EMDN Code
- Z12149099 VARIOUS ENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Hearing aid tester, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3310 FDA UDI
- Market of Registration
- Italy 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hearing aid tester, electrical
Drum by Inventis Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Inventis Srl
Sources (2)
- FDA UDI e1fe3f98-465f-41b5-b142-a9027e6f0bc6 35 fields · synced Jun 18, 2026
- EUDAMED f3ecf0c1-f44d-43f3-988c-7fe2f34d6faa 61 fields · synced Jun 18, 2026