← Back to catalogue
Diplomat
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref SIRIUS ESSENTIAL, SIRIUS PLUS, SIRIUS POWER, SIRIUS ULTRAModel XENOS, SIRIUS DS 1510(k) K130534
Identity
- Trade Name
- DIPLOMAT EUDAMED
- Device Name
- Dental light EUDAMED
- Model / Reference
- XENOS, SIRIUS DS 1 EUDAMEDSIRIUS ESSENTIAL, SIRIUS PLUS, SIRIUS POWER, SIRIUS ULTRA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588007067803 EUDAMED
- Basic UDI-DI
- 8588007067DENTALLIGHTL2 EUDAMED
- Direct Marketing DI
- 08588007067803 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Operating room light system
Diplomat by DIPLOMAT DENTAL s.r.o. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light system.
- PWDII70DF CL K3 SATX13 — MAQUET SAS · Class I
- PWDII70SF SAT AIM CL K4 12 — MAQUET SAS · Class I
- PWDII50SF AIM MHS021 K4 1116 — MAQUET SAS · Class I
- PWDII55DF CL K4 SAX0810 — MAQUET SAS · Class I
- SLS 9000 — Avante · Class II
- PWDII75SF AIM MHS021 K3 081011 — MAQUET SAS · Class I
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130534 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8588007067DENTALLIGHTL2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DIPLOMAT DENTAL s.r.o.
- EUDAMED SRN
- SK-MF-000002562
Sources (3)
- EUDAMED da255375-1ecc-49d6-8546-259a158cf06a 85 fields · synced Jul 18, 2026
- EUDAMED da255375-1ecc-49d6-8546-259a158cf06a-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K130534 1 fields · synced May 18, 2026