H3+ Patient Cable
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- H3+ Patient Cable EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Patient cable cleared with H3+ recorder FDA UDI
- Model / Reference
- 9293-036-63 EUDAMEDFDA UDI901006 EUDAMED
- Description
- Patient cable cleared with H3+ recorder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812345025040 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901006DNN EUDAMED
- 510(k) Number
- K152626 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050480 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrocardiographic lead set, reusable
H3+ Patient Cable 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.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K152626 also covers:
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
- H3+ Patient Cable — MORTARA INSTRUMENT, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (2)
- FDA UDI 7b1b5369-858c-4a9b-965c-b92bafc7c5e3 36 fields · synced Jul 15, 2026
- EUDAMED 9c9e7172-8e8a-4476-befe-dcc97c761c5c 61 fields · synced Jul 15, 2026