Identity
- Trade Name
- 360° Endoscopic Applicator EUDAMED
- Device Name
- 360° Spray Set Endoscopic Applicator with Tether EUDAMED
- Model / Reference
- SA-3768 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20815634020676 EUDAMED10815634020679 EUDAMED
- Basic UDI-DI
- B-20815634020676 EUDAMEDB-10815634020679 EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
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
360° Endoscopic Applicator by Micromedics, Inc. — Class IIa — 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 | K120608 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-20815634020676 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 8a7802fc-f3bd-41b4-aceb-cde41edf090e 61 fields · synced Jul 24, 2026
- EUDAMED 64a14a3f-597f-43b5-9cdb-2771f90f5e9e 61 fields · synced May 17, 2026
- FDA 510(k) K120608 1 fields · synced May 18, 2026