Identity
- Trade Name
- Welch Allyn EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- Welch Allyn Elite 3.5 V Halogen HPX Streak Retinoscope; Power Handle Not Included FDA UDI
- Model / Reference
- 901024 EUDAMEDFDA UDI18240 EUDAMED
- Description
- Welch Allyn Elite 3.5 V Halogen HPX Streak Retinoscope; Power Handle Not Included FDA UDI
Identifiers
- Catalog Number
- 18240 FDA UDI
- Primary DI / UDI-DI
- 00732094087741 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901024EU EUDAMED
- FDA Product Code
- HKM FDA UDI
- EMDN Code
- Z12120118 RETINOSCOPES EUDAMED
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1780 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 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 | 0732094GMN901024EU | 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 (2)
- EUDAMED 443d6d07-d8a2-4461-b2ae-ee7df223b191 61 fields · synced Jul 9, 2026
- FDA UDI cd3a3260-7012-451d-b8ea-66e9c4a1130c 35 fields · synced May 30, 2026