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Graftys Hbs
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref GYHBSV1Q16510(k) K082498Ref GYHBSV1Q8Ref GYHBSV1Q5
by Graftys
Identity
- Trade Name
- GRAFTYS HBS EUDAMED
- Device Name
- GRAFTYS HBS EUDAMED
- Model / Reference
- GYHBSV1Q16 EUDAMEDGYHBSV1Q8 EUDAMEDGYHBSV1Q5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760177571242 EUDAMED03760177571235 EUDAMED03760177571228 EUDAMED
- Basic UDI-DI
- B-03760177571242 EUDAMEDB-03760177571235 EUDAMEDB-03760177571228 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Graftys Hbs by Graftys — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082498 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-03760177571242 | Class III | No Longer Active |
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Manufacturer
- Manufacturer
- Graftys
- EUDAMED SRN
- FR-MF-000019838
Sources (4)
- EUDAMED 7640390c-951d-425b-a834-686a5039a289 85 fields · synced Jul 25, 2026
- EUDAMED 5e3348e3-03cb-4aef-9d51-557b2f1ed48c 61 fields · synced May 18, 2026
- EUDAMED 83e7505d-ab7e-4496-a5c6-39ff318cda5d 61 fields · synced May 18, 2026
- FDA 510(k) K082498 1 fields · synced May 18, 2026