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Striate+
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref OCG-152, OCG-203, OCG-304, OCG-405, OCG-050, OCG-070510(k) K201241
Identity
- Trade Name
- Striate+ EUDAMED
- Device Name
- Striate+ EUDAMED
- Model / Reference
- OCG-152, OCG-203, OCG-304, OCG-405, OCG-050, OCG-070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AU-MF-000018345Z8 EUDAMED
- Basic UDI-DI
- B-AU-MF-000018345Z8 EUDAMED
- EMDN Code
- Q010301 PERIODONTAL MEMBRANES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
Striate+ by Orthocell Ltd — 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 Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201241 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-AU-MF-000018345Z8 | Class III | Active |
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Manufacturer
- Manufacturer
- Orthocell Ltd
- EUDAMED SRN
- AU-MF-000018345
- FDA Applicant
- Orthocell, Ltd.
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 3b2ce26e-972e-4ae5-8f27-9765667077b3 85 fields · synced Jul 18, 2026
- EUDAMED 3b2ce26e-972e-4ae5-8f27-9765667077b3-1 61 fields · synced Jun 10, 2026
- FDA 510(k) K201241 1 fields · synced May 18, 2026