Identity
- Trade Name
- ZMAC EUDAMEDZurich Medical Accessory Cable (ZMAC), GE 7-Pin, Type A EUDAMEDZurich Medical Accessory Cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Zurich Medical Accessory Cable, GE 7-Pin, Type A EUDAMEDZurich Medical Accessory Cable EUDAMED
- Model / Reference
- 00512-001 EUDAMEDGE-7-Pin, Type A FDA UDI
Identifiers
- Catalog Number
- 512-001 FDA UDI
- Primary DI / UDI-DI
- 00850022994012 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
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Zmac by Zurich Medical — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850022994005128W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zurich Medical
- EUDAMED SRN
- US-MF-000012091
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (3)
- EUDAMED 15a0cf5a-02db-4abd-b433-966f1f3fa17d 61 fields · synced Jun 19, 2026
- FDA UDI 7b35595b-7804-4395-9e5b-46229c091766 34 fields · synced May 30, 2026
- EUDAMED 541961ea-d423-47e7-afc3-e5bd6cb1ac82 61 fields · synced Jun 19, 2026