Identity
- Trade Name
- AM12 EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Wired Acquisition System cleared with the ELI 230 Electrocardiograph FDA UDI
- Model / Reference
- 9293-048-54 EUDAMEDFDA UDI901095 EUDAMED
- Description
- Wired Acquisition System cleared with the ELI 230 Electrocardiograph FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812345029680 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901095CPW EUDAMED
- 510(k) Number
- K100127 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic lead set, reusable
Am12 by Mortara Instrument, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K100127 also covers:
- AM12 — MORTARA INSTRUMENT, INC.
- AM12 — MORTARA INSTRUMENT, INC.
- AM12 — MORTARA INSTRUMENT, INC.
- AM12 — MORTARA INSTRUMENT, INC.
- AM12 — MORTARA INSTRUMENT, INC.
- AM12 — MORTARA INSTRUMENT, INC.
- AM15E — MORTARA INSTRUMENT, INC.
- ELI 230 — MORTARA INSTRUMENT, INC.
- ELI 230 — MORTARA INSTRUMENT, INC.
- ELI 230 — MORTARA INSTRUMENT, INC.
- ELI 230 — MORTARA INSTRUMENT, INC.
- WAM — MORTARA INSTRUMENT, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (2)
- FDA UDI f4348137-59ba-477f-88f5-7b7438afdffd 36 fields · synced Jul 29, 2026
- EUDAMED b0e32bc4-cab5-4e08-80ac-db6b5a8c38c9 61 fields · synced Jul 29, 2026