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PanOptic
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 118-2Model 901022510(k) K121405
Identity
- Trade Name
- PanOptic EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Welch Allyn PanOptic 2 Ophthalmoscope FDA UDI
- Model / Reference
- 901022 EUDAMEDFDA UDI118-2 EUDAMED
- Description
- Welch Allyn PanOptic 2 Ophthalmoscope FDA UDI
Identifiers
- Catalog Number
- 118-2 FDA UDI
- Primary DI / UDI-DI
- 00732094320732 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901022EQ EUDAMED
- FDA Product Code
- HLI FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Ophthalmic/otologic diagnostic set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PanOptic by Welch Allyn, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121405 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0732094GMN901022EQ | Class I | Active |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
- EUDAMED SRN
- US-MF-000013394
- Authorised Representative
- Welch Allyn Limited IE-AR-000000768
Sources (3)
- EUDAMED 74293598-0418-4023-ba9f-9a44806804c6 85 fields · synced Jun 18, 2026
- FDA UDI d39f33ab-cdd2-4d84-8758-13ece022b052 35 fields · synced May 26, 2026
- FDA 510(k) K121405 1 fields · synced May 18, 2026