Identity
- Trade Name
- zumax FDA UDI
- Generic Name
- Direct otoscope/audiometer FDA UDI
- Device Name
- otoscope bulb 2.5V FDA UDI
- Model / Reference
- T4954 FDA UDI
- Description
- otoscope bulb 2.5V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945095520986 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Direct otoscope/audiometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Direct otoscope/audiometer
zumax by Zumax Medical Co., LTD — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Direct otoscope/audiometer.
- Otoscope — Rashman Corp. · Class I
- Otoscope — Rashman Corp. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Otoscope — Rashman Corp. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zumax Medical Co., LTD
Sources (1)
- FDA UDI 47bbb8dd-a3f4-4b27-a697-3c6c780cd0dd 33 fields · synced May 30, 2026