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Synvisc
EUDAMEDClass III (EU MDR)
Ref Not ApplicableModel Synvisc 3 syringes of 2mL
Identity
- Trade Name
- Synvisc EUDAMED
- Device Name
- Hylan G-F 20 EUDAMED
- Model / Reference
- Synvisc 3 syringes of 2mL EUDAMEDNot Applicable EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-US-MF-000007947-3x2mlVA EUDAMED
- Basic UDI-DI
- B-US-MF-000007947-3x2mlVA EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Synvisc by Genzyme Corp. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-US-MF-000007947-3x2mlVA | Class III | Active |
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Manufacturer
- Manufacturer
- Genzyme Corporation
- EUDAMED SRN
- US-MF-000007947
- Authorised Representative
- Sanofi B.V. NL-AR-000005218
Sources (1)
- EUDAMED 3fe91e4f-4994-439d-92de-2a2c92b0089c 61 fields · synced Jun 18, 2026