Identity
- Trade Name
- RT300 EUDAMED
- Device Name
- RT300-SL EUDAMED
- Model / Reference
- FA100052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *M720FA1000520U* EUDAMED
- Basic UDI-DI
- B-*M720FA1000520U* EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Rt300 by Restorative Therapies, Inc. — Class IIa — 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-*M720FA1000520U* | Class IIa | Active |
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Manufacturer
- Manufacturer
- Restorative Therapies, Inc.
- EUDAMED SRN
- US-MF-000023084
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c9737a7e-7e0d-4e5f-9bff-6291e61fc06d 61 fields · synced May 23, 2026