Identity
- Trade Name
- HEINE - EN 100 TRANSFORMER ONLY FDA UDI
- Generic Name
- Indirect binocular ophthalmoscope FDA UDI
- Device Name
- HEINE - EN 100 TRANSFORMER ONLY FDA UDI
- Model / Reference
- X-095.12.110 FDA UDI
- Description
- HEINE - EN 100 TRANSFORMER ONLY FDA UDI
Identifiers
- Catalog Number
- X-095.12.110 FDA UDI
- Primary DI / UDI-DI
- 00192896009608 FDA UDI
- 510(k) Number
- K142486 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Indirect binocular ophthalmoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Indirect binocular ophthalmoscope
Heine - En 100 Transformer Only by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142486 also covers:
- BETA 4 NT RECHARGEABLE HANDLE — SONTEC INSTRUMENTS, INC.
- BETA 4 USB LI-ION RECHARABLE HANDLE — SONTEC INSTRUMENTS, INC.
- HEINE - BETA R HANDLE — SONTEC INSTRUMENTS, INC.
- HEINE - LITHIUM ION BATTERY — SONTEC INSTRUMENTS, INC.
- HEINE - MPACK PLUG-IN TRANSFORMER — SONTEC INSTRUMENTS, INC.
- HEINE - PLUG IN TRANSFORMER — SONTEC INSTRUMENTS, INC.
- HEINE HC 50 CONNECTING CORD — SONTEC INSTRUMENTS, INC.
- HEINE LI-ION BATTERY — SONTEC INSTRUMENTS, INC.
- HEINE MPACK — SONTEC INSTRUMENTS, INC.
- HEINE MPACK COMPLETE — SONTEC INSTRUMENTS, INC.
- HEINE MPACK LL BATTERY PACK — SONTEC INSTRUMENTS, INC.
- HEINE MPACK MINI — SONTEC INSTRUMENTS, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI e5830c61-d8db-4ffa-8457-5428adeb96dd 36 fields · synced May 30, 2026