Identity
- Trade Name
- GPG EUDAMEDZurich Pressure Guidewire System FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- Zurich Pressure Guidewire System, Model 100 EUDAMED
- Model / Reference
- 100 EUDAMED00308 EUDAMEDModel 100 FDA UDI
Identifiers
- Catalog Number
- 308 FDA UDI
- Primary DI / UDI-DI
- 00850022994005 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850022994005 EUDAMED
- 510(k) Number
- K190852 FDA UDI
- FDA Product Code
- DXO FDA UDIDQK FDA UDIDSK FDA UDIDQX FDA UDI
- EMDN Code
- C04010101 CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2870 FDA UDI870.1425 FDA UDI870.1110 FDA UDI870.1330 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gpg by Zurich Medical — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850022994005 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | 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 (2)
- EUDAMED 2b894459-3801-425e-836f-fb48ac7f9fec 61 fields · synced Jul 28, 2026
- FDA UDI b9a51682-4c3b-4613-84d8-41451ffa0c3e 34 fields · synced May 30, 2026