Identity
- Trade Name
- Welch Allyn EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- Welch Allyn 2.0 mm Reusable Ear Specula for Pneumatic, Operating, and Consulting Otoscopes FDA UDI
- Model / Reference
- 901001 EUDAMEDFDA UDI22002 EUDAMED
- Description
- Welch Allyn 2.0 mm Reusable Ear Specula for Pneumatic, Operating, and Consulting Otoscopes FDA UDI
Identifiers
- Catalog Number
- 22002 FDA UDI
- Primary DI / UDI-DI
- 00732094086096 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901001EG EUDAMED
- FDA Product Code
- ERA FDA UDI
- EMDN Code
- Z12149085 VARIOUS ENT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Otoscope, direct 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 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 | 0732094GMN901001EG | Class I | Active |
| 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.
- EUDAMED SRN
- US-MF-000013394
- Authorised Representative
- Welch Allyn Limited IE-AR-000000768
Sources (2)
- EUDAMED c17ba816-bd98-40a1-a99e-6be1179b3484 61 fields · synced Jun 20, 2026
- FDA UDI 20090f3b-0b7a-4aff-aa61-0cd5047a627d 35 fields · synced May 30, 2026