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Synvisc
EUDAMEDClass III (EU MDR)
Ref Not ApplicableModel Synvisc 1 syringe of 2mLModel Synvisc-One 1 syringe of 6mL
Identity
- Trade Name
- Synvisc EUDAMEDSynvisc-One EUDAMED
- Device Name
- Hylan G-F 20 EUDAMED
- Model / Reference
- Synvisc 1 syringe of 2mL EUDAMEDNot Applicable EUDAMEDSynvisc-One 1 syringe of 6mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-US-MF-000007947-1x2mlUL EUDAMEDD-US-MF-000007947-1x6mlV8 EUDAMED
- Basic UDI-DI
- B-US-MF-000007947-1x2mlUL EUDAMEDB-US-MF-000007947-1x6mlV8 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-000007947-1x2mlUL | 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 (2)
- EUDAMED e71d90de-8af8-454f-9679-28f76dbd08d0 61 fields · synced Jul 19, 2026
- EUDAMED 2102f3b3-a534-4723-ac47-79023681ae37 61 fields · synced May 18, 2026