Identity
- Trade Name
- Welch Allyn EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Welch Allyn SureColor LED 2.5 V Pocket Plus Ophthalmoscope; AA-Battery Handle, Soft Storage Case, Matching Handle Bumpers; Blueberry; 2 Alkaline AA Batteries FDA UDIPOCKETPLUS LED OPH HEAD AND HNDL BLUE FDA UDI
- Model / Reference
- 901082 EUDAMEDFDA UDI12880-BLU EUDAMED
- Description
- Welch Allyn SureColor LED 2.5 V Pocket Plus Ophthalmoscope; AA-Battery Handle, Soft Storage Case, Matching Handle Bumpers; Blueberry; 2 Alkaline AA Batteries FDA UDIPOCKETPLUS LED OPH HEAD AND HNDL BLUE FDA UDI
Identifiers
- Catalog Number
- 12880-BLU FDA UDI410289 FDA UDI
- Primary DI / UDI-DI
- 00732094196016 EUDAMEDFDA UDI00732094204186 FDA UDI
- Basic UDI-DI
- 0732094GMN901082FA EUDAMED
- FDA Product Code
- ERA FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Ophthalmic/otologic diagnostic set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4770 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Welch Allyn by Welch Allyn, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732094GMN901082FA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 4701b8cc-fee9-4b88-ba78-d24b14c2f47e 61 fields · synced May 31, 2026
- FDA UDI 215b24df-53c6-4af3-9f84-fce0b596cb5b 35 fields · synced May 29, 2026
- FDA UDI 451f0994-fcd6-461e-a460-64cb53badd61 35 fields · synced May 30, 2026