Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Welch Allyn 3.5 V Halogen HPX Diagnostic Set including PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), Rechargeable 1 20-Minute Power Handle(s), Hard Storage Case; Lithium-Ion (#71960) Battery; IEC Plug Type-A FDA UDI
- Model / Reference
- 901026 FDA UDI
- Description
- Welch Allyn 3.5 V Halogen HPX Diagnostic Set including PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), Rechargeable 1 20-Minute Power Handle(s), Hard Storage Case; Lithium-Ion (#71960) Battery; IEC Plug Type-A FDA UDI
Identifiers
- Catalog Number
- 97150-MPS FDA UDI
- Primary DI / UDI-DI
- 00732094103687 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set 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
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: Ophthalmic/otologic diagnostic set
Welch Allyn, Inc. by Welch Allyn, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic/otologic diagnostic set.
- Adstation™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Adstation™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class I
- Adstation™ — American Diagnostic Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 88be0dd5-5e48-4a6f-98cb-9697f8638160 35 fields · synced Jun 6, 2026