Identity
- Trade Name
- Mini otoscope 3000 FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- with battery handle 2.5 V batteries 4 multi use ear specula FDA UDI
- Model / Reference
- 10-143-00 FDA UDI
- Description
- with battery handle 2.5 V batteries 4 multi use ear specula FDA UDI
Identifiers
- Catalog Number
- 10-143-00 FDA UDI
- Primary DI / UDI-DI
- 04053755125494 FDA UDI
- FDA Product Code
- EQH FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4350 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Otoscope, direct
Mini otoscope 3000 by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Otoscope, direct.
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- BETA 200 VET. OTOSCOPE — Heine Optotechnik GmbH & Co. KG · Class I
- Firefly — Firefly Global · Class I
- Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
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
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI 103f5287-6d8d-4027-83a4-4aaba00fcca2 35 fields · synced May 30, 2026