MPK-4-R/2, 0m
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MPK-4-R/2,0 m EUDAMEDMPK-4-R/2,0m FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- 353177 EUDAMEDFDA UDIDiagnostic cable EUDAMED
Identifiers
- Catalog Number
- 353177 FDA UDI
- Primary DI / UDI-DI
- 04035479092436 EUDAMEDFDA UDI
- Basic UDI-DI
- 4035479BUDI00093QK EUDAMED
- Direct Marketing DI
- 04035479092436 EUDAMED
- FDA Product Code
- DRF FDA UDI
- EMDN Code
- C020180 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
MPK-4-R/2, 0m by BIOTRONIK SE & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- MICTEC CONNECTION CABLE — SONTEC INSTRUMENTS, INC. · Class II
- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K201445 also covers:
- MPK-10-R/2, 0m — BIOTRONIK SE & Co. KG
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
- AcQRate Dx Fixed Curve Catheter — VascoMed GmbH
K212593 also covers:
- MPK-10-R/2, 0m — BIOTRONIK SE & Co. KG
- AcQRate Dx Steerable Catheter — VascoMed GmbH
- AcQRate Dx Steerable Catheter — VascoMed GmbH
- AcQRate Dx Steerable Catheter — VascoMed GmbH
- AcQRate Dx Steerable Catheter — VascoMed GmbH
- AcQRate Dx Steerable Catheter — VascoMed GmbH
- AcQRate Dx Steerable Catheter — VascoMed GmbH
- AcQRate Dx Steerable Catheter — VascoMed GmbH
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
- BIOTRONIK SE & Co. KG
Sources (2)
- FDA UDI 07f9e1b7-609c-482c-b304-0de2b134ccc7 36 fields · synced Jul 20, 2026
- EUDAMED c1e7fb05-13b1-4e05-b8d2-43bf3c296a9d 61 fields · synced Jul 20, 2026