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Welch Allyn Harvey Elite Stethoscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5079-122SModel 901039
Identity
- Trade Name
- Welch Allyn Harvey Elite Stethoscope EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Device Name
- Welch Allyn Harvey Elite Cardiology Stethoscope with Stainless Steel Double-Head Chestpiece (Adult Diaphragm and Low-Frequency Bell) , Dual Lumen Latex-Free Tubing; 22 in/55.9 cm; Black FDA UDI
- Model / Reference
- 901039 EUDAMEDFDA UDI5079-122S EUDAMED
- Description
- Welch Allyn Harvey Elite Cardiology Stethoscope with Stainless Steel Double-Head Chestpiece (Adult Diaphragm and Low-Frequency Bell) , Dual Lumen Latex-Free Tubing; 22 in/55.9 cm; Black FDA UDI
Identifiers
- Catalog Number
- 5079-122S FDA UDI
- Primary DI / UDI-DI
- 00732094000535 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901039F9 EUDAMED
- FDA Product Code
- LDE FDA UDI
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
- GMDN Term
- Mechanical external stethoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.1875 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Welch Allyn Harvey Elite Stethoscope 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 | 0732094GMN901039F9 | 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 8240d848-9a3f-414c-b0aa-204f9e7269ff 61 fields · synced Jun 17, 2026
- FDA UDI 133c2a51-6d12-41d7-bd12-f198a8f5f24c 35 fields · synced May 30, 2026