Zurich Medical Accessory Cable
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Zurich Medical Accessory Cable (ZMAC), GE 7-Pin, Type G EUDAMEDZurich Medical Accessory Cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Zurich Medical Accessory Cable EUDAMED
- Model / Reference
- 00512-003 EUDAMEDGE 7-Pin, Type G FDA UDI
Identifiers
- Catalog Number
- 512-003 FDA UDI
- Primary DI / UDI-DI
- 00850022994036 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850022994005128W EUDAMED
- 510(k) Number
- K190852 FDA UDI
- FDA Product Code
- DSK FDA UDIDQK FDA UDI
- EMDN Code
- C0480 CARDIOVASCULAR GUIDEWIRES - ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1110 FDA UDI870.1425 FDA UDI
- Market of Registration
- Czechia 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
No
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
Yes
Category: Electrical-only medical device connection cable, reusable
Zurich Medical Accessory Cable by Zurich Medical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection cable, reusable.
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Cleared under the same submission
K190852 also covers:
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
- Zurich Medical Accessory Cable — Zurich Medical
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
- Zurich Medical
Sources (2)
- FDA UDI 9a826ca5-bd07-49d7-8415-ca5249130e58 34 fields · synced Jun 18, 2026
- EUDAMED 14ebf6c9-3c0f-4395-af19-877feaa03334 61 fields · synced Jun 18, 2026