Kera
by Huzur Dental Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 15 variants
Ref OS-0200, EKO-0250, AM-0001, EKO-0050, PY-0010, SK-0250, DL-1000, MM-0200, RL-0050, DB-5000, GL-0050, MR-0500, CM-0001, DP-1000, PV-0020, RL-5000, İAA-0250, BK-5000, A-5000, AY-0020, IB-0050, DL-0250, PM-0500
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8682276255OS-0200JJ | Date17 Dec 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Occlusion SprayExtra Creamy Opaquer LiquidPontic WaxPorcelain EtchCanal WaxModelling LiquidModelling WaxColorful LiquidDublicatGlaze Liquid3D Modelling ResinCad Cam Modelling BlocksDental PumicePorcelain VarnishInvestmentImplant Plaster a LiquidOxide White Sand 500 MicronAcidSeparating OilLight Cure Base PlatePink Candle /Modelling
- Model / Reference
- OS-0200, EKO-0250, AM-0001, EKO-0050, PY-0010, SK-0250, DL-1000, MM-0200, RL-0050, DB-5000, GL-0050, MR-0500, CM-0001, DP-1000, PV-0020, RL-5000, İAA-0250, BK-5000, A-5000, AY-0020, IB-0050, DL-0250, PM-0500
- Primary DI / UDI-DI
- 08682276255555, 08682276255036, 08682276255432, 08682276255029, 08682276255173, 08682276255449, 08682276255012, 08682276255425, 08682276255074, 08682276255500, 08682276255050, 08682276255609, 08682276255401, 08682276255470, 08682276255098, 08682276255517, 08682276255210, 08682276255548, 08682276255319, 08682276255081, 08682276255487, 08682276255005, 08682276255494
- Basic UDI-DI
- 8682276255OS-0200JJ, 8682276255EKO-CK, 8682276255AM-00018E, 8682276255PY-0010MA, 8682276255SK-0250HV, 8682276255DL-FK, 8682276255MM-0200F2, 8682276255RL-0050HF, 8682276255DB-50006K, 8682276255GL-G2, 8682276255MR-0500HJ, 8682276255CM-00019G, 8682276255DP-1000BD, 8682276255PV-0020L6, 8682276255RL-5000J3, 8682276255IAA-0250JK, 8682276255BK-500096, 8682276255A-5000UW, 8682276255AY-0020DE, 8682276255IB-00508L, 8682276255PM-0500H4
- Direct Marketing DI
- 0868227625555508682276255036086822762554320868227625502908682276255173086822762554490868227625501208682276255425086822762550740868227625550008682276255050086822762556090868227625540108682276255470086822762550980868227625551708682276255210086822762555480868227625531908682276255081086822762554870868227625500508682276255494
- EMDN Code
- Q01020202, Q01020601, Q01020602, Q01020603, Q01020604, Q01020605, Q0101010201, Q0101010202, Q0101010203, Q0101010204, Q0101010299, Q02030301
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000019287
Other devices from Huzur Dental Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
See all devices from Huzur Dental Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No