Welch Allyn, Inc.
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AM12 EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- AM12 acquisition module with 10 wire IEC lead set with banana plugss FDA UDI
- Model / Reference
- 901095 EUDAMEDFDA UDI41000-032-51 EUDAMED
- Description
- AM12 acquisition module with 10 wire IEC lead set with banana plugss FDA UDI
Identifiers
- Catalog Number
- 41000-032-51 FDA UDI
- Primary DI / UDI-DI
- 00732094272109 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901095CPW EUDAMED
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiograph, professional, multichannel
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (2)
- FDA UDI 6b759620-7c02-431a-883d-c13ad0aa3f63 35 fields · synced Jun 19, 2026
- EUDAMED 7aa06cd7-351a-47aa-830e-90563fcfbfe3 61 fields · synced Jun 19, 2026