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AVVIGO Family Guidance Systems
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref H749555100R0
Identity
- Trade Name
- FFR Link FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- AVVIGO Family Guidance Systems EUDAMEDFFR Signal Processing Module FDA UDI
- Model / Reference
- H749555100R0 EUDAMEDFDA UDI
- Description
- FFR Signal Processing Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729939603 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000269NE EUDAMED
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- C010499 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Market of Registration
- Netherlands 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AVVIGO Family Guidance Systems by Boston Scientific Corporation — Class IIa — 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 | 01915060000000000000269NE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 524703fd-e508-4e69-af74-d8998e8946a2 61 fields · synced Oct 6, 2026
- FDA UDI fc2c78c3-aedb-4138-92d0-c8fbfd23f12e 33 fields · synced May 30, 2026