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Diplomat
EUDAMEDClass IIa (EU MDR)
Ref TYGI 300 BModel MODEL PRO 800, MODEL PRO 700Ref TYGI 400 BRef TYGI 400 LRef TYGI 550 BRef DC 310Ref MODEL ALFARef DC 290Ref DC 170Ref TYGI 300 LRef TYGI 500 LRef TYGI 200 BRef MODEL ONE 100Ref DL 210 Ref MODEL ZERORef XenosModel XENOS, SIRIUS DS 1Ref TYGI 200 LRef DA 170Ref TYGI 350 LRef MODEL ONE 200
Identity
- Trade Name
- DIPLOMAT EUDAMED
- Device Name
- Dental units EUDAMEDDental light EUDAMED
- Model / Reference
- MODEL PRO 800, MODEL PRO 700 EUDAMEDTYGI 300 B EUDAMEDTYGI 400 B EUDAMEDTYGI 400 L EUDAMEDTYGI 550 B EUDAMEDDC 310 EUDAMEDMODEL ALFA EUDAMEDDC 290 EUDAMEDDC 170 EUDAMEDTYGI 300 L EUDAMEDTYGI 500 L EUDAMEDTYGI 200 B EUDAMEDMODEL ONE 100 EUDAMEDDL 210 EUDAMEDMODEL ZERO EUDAMEDXENOS, SIRIUS DS 1 EUDAMEDXenos EUDAMEDTYGI 200 L EUDAMEDDA 170 EUDAMEDTYGI 350 L EUDAMEDMODEL ONE 200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588007067612 EUDAMED08588007067629 EUDAMED08588007067728 EUDAMED08588007067575 EUDAMED08588007067094 EUDAMED08588007067162 EUDAMED08588007067681 EUDAMED08588007067049 EUDAMED08588007067711 EUDAMED08588007067759 EUDAMED08588007067704 EUDAMED08588007067698 EUDAMED08588007067087 EUDAMED08588007067179 EUDAMED08588007067797 EUDAMED08588007067568 EUDAMED08588007067063 EUDAMED08588007067742 EUDAMED08588007067551 EUDAMED
- Basic UDI-DI
- 8588007067DENTALUNITK505C EUDAMED8588007067DENTALLIGHTL2 EUDAMED
- Direct Marketing DI
- 08588007067612 EUDAMED08588007067629 EUDAMED08588007067728 EUDAMED08588007067575 EUDAMED08588007067094 EUDAMED08588007067162 EUDAMED08588007067681 EUDAMED08588007067049 EUDAMED08588007067711 EUDAMED08588007067759 EUDAMED08588007067704 EUDAMED08588007067698 EUDAMED08588007067087 EUDAMED08588007067179 EUDAMED08588007067797 EUDAMED08588007067568 EUDAMED08588007067063 EUDAMED08588007067742 EUDAMED08588007067551 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMEDZ12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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: Dental delivery system
Diplomat by DIPLOMAT DENTAL s.r.o. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8588007067DENTALUNITK505C | Class IIa | Active |
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Manufacturer
- Manufacturer
- DIPLOMAT DENTAL s.r.o.
- EUDAMED SRN
- SK-MF-000002562
Sources (19)
- EUDAMED 5dd2abd8-58f3-4249-b651-b39ca146a2f2 61 fields · synced Sep 18, 2026
- EUDAMED 2f595922-4b69-497f-978f-4374055246b4 61 fields · synced May 16, 2026
- EUDAMED 35b05ece-f4be-423c-a53f-de39a0b012ed 61 fields · synced May 16, 2026
- EUDAMED ae4481c5-c943-41e3-bda5-c9e900744763 61 fields · synced May 16, 2026
- EUDAMED aee91890-3963-42e2-8cd8-a9df4a6d995a 61 fields · synced May 16, 2026
- EUDAMED 88451555-5945-4204-a2f3-55859f49bb4d 61 fields · synced May 17, 2026
- EUDAMED 5b18b2fc-1fa6-48c9-a812-2f96864d5796 61 fields · synced May 17, 2026
- EUDAMED 0805e2e9-e21d-4b23-a52f-2072efc76992 61 fields · synced May 17, 2026
- EUDAMED 99dc2198-181a-4be2-96bd-9c1ca4148d0e 61 fields · synced May 17, 2026
- EUDAMED dbdff1c5-ac22-445f-a2fb-034fa00c6dec 61 fields · synced May 17, 2026
- EUDAMED 32d16cb8-d5e2-45d8-b4aa-84e5385a590b 61 fields · synced May 17, 2026
- EUDAMED 86e31e01-bc4d-4330-9170-cc50eadd1c82 61 fields · synced May 18, 2026
- EUDAMED 0646ada3-7a51-4239-af05-be0e77668e51 61 fields · synced May 18, 2026
- EUDAMED 0912f2fa-43a4-4c2e-b15a-ebb9cf7ff471 61 fields · synced May 18, 2026
- EUDAMED e1b0a806-c207-403c-a39f-890983417ad4 61 fields · synced May 18, 2026
- EUDAMED 4beb0e41-0866-4616-b736-e21849ffe6a4 61 fields · synced May 18, 2026
- EUDAMED 0b5c69d7-23b8-4535-96c7-b4f30a5176ca 61 fields · synced May 18, 2026
- EUDAMED 3bce1023-8850-417c-a028-98f220b47b65 61 fields · synced May 19, 2026
- EUDAMED 6b9544c8-4ee4-49fb-9cf9-a592c4454fb1 61 fields · synced May 19, 2026