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Edge Sequel Sapphire

EUDAMED

Class IIa (EU MDR)

Ref ES200625HTSModel S1.7B0.00.0FI.FKRef ES600421HTSRef ES06153031ASSTRef ES500625HTSRef ES700431HTSRef ES150431HTSRef ES150621HTSRef ES06355025ASSTRef ES700421HTSRef ES06153021ASSTRef ES500631HTSRef ES450425HTSRef ES350625HTSRef ES500621HTSRef ES900425HTSRef ES250625HTSRef ES600431HTSRef ES300631HTSRef ES600425HTSRef ES350621HTSRef ES800421HTSRef ES04355031ASSTRef ES550425HTSRef ES400425HTSRef ES250831HTSRef ES300621HTSRef ES150421HTSRef ES900431HTSRef ES250431HTSRef ES450631HTSRef ES200425HTSRef ES700425HTSRef ES04153021ASSTRef ES200621HTSRef ES350421HTSRef ES900421HTSRef ES200431HTSRef ES150631HTSRef ES04153031ASSTRef ES06153025ASSTRef ES300421HTSRef ES550421HTSRef ES300431HTSRef ES400431HTSRef ES500431HTS

by FKG Dentaire Sàrl

Identity

Trade Name
EDGE SEQUEL SAPPHIRE EUDAMED
Device Name
R-Motion EUDAMED
Model / Reference
S1.7B0.00.0FI.FK EUDAMED
ES200625HTS EUDAMED
ES600421HTS EUDAMED
ES06153031ASST EUDAMED
ES500625HTS EUDAMED
ES700431HTS EUDAMED
ES150431HTS EUDAMED
ES150621HTS EUDAMED
ES06355025ASST EUDAMED
ES700421HTS EUDAMED
ES06153021ASST EUDAMED
ES500631HTS EUDAMED
ES450425HTS EUDAMED
ES350625HTS EUDAMED
ES500621HTS EUDAMED
ES900425HTS EUDAMED
ES250625HTS EUDAMED
ES600431HTS EUDAMED
ES300631HTS EUDAMED
ES600425HTS EUDAMED
ES350621HTS EUDAMED
ES800421HTS EUDAMED
ES04355031ASST EUDAMED
ES550425HTS EUDAMED
ES400425HTS EUDAMED
ES250831HTS EUDAMED
ES300621HTS EUDAMED
ES150421HTS EUDAMED
ES900431HTS EUDAMED
ES250431HTS EUDAMED
ES450631HTS EUDAMED
ES200425HTS EUDAMED
ES700425HTS EUDAMED
ES04153021ASST EUDAMED
ES200621HTS EUDAMED
ES350421HTS EUDAMED
ES900421HTS EUDAMED
ES200431HTS EUDAMED
ES150631HTS EUDAMED
ES04153031ASST EUDAMED
ES06153025ASST EUDAMED
ES300421HTS EUDAMED
ES550421HTS EUDAMED
ES300431HTS EUDAMED
ES400431HTS EUDAMED
ES500431HTS EUDAMED

Identifiers

Primary DI / UDI-DI
07640452461559 EUDAMED
07640452461993 EUDAMED
07640452462167 EUDAMED
07640452461948 EUDAMED
07640452462044 EUDAMED
07640452461474 EUDAMED
07640452461481 EUDAMED
07640452462211 EUDAMED
07640452462020 EUDAMED
07640452462143 EUDAMED
07640452461955 EUDAMED
07640452461856 EUDAMED
07640452461764 EUDAMED
07640452461931 EUDAMED
07640452462099 EUDAMED
07640452461610 EUDAMED
07640452462013 EUDAMED
07640452461719 EUDAMED
07640452462006 EUDAMED
07640452461757 EUDAMED
07640452462051 EUDAMED
07640452462198 EUDAMED
07640452461979 EUDAMED
07640452461795 EUDAMED
07640452461658 EUDAMED
07640452461696 EUDAMED
07640452461450 EUDAMED
07640452462105 EUDAMED
07640452461597 EUDAMED
07640452461894 EUDAMED
07640452461528 EUDAMED
07640452462037 EUDAMED
07640452462112 EUDAMED
07640452461542 EUDAMED
07640452461726 EUDAMED
07640452462082 EUDAMED
07640452461535 EUDAMED
07640452461504 EUDAMED
07640452462136 EUDAMED
07640452462150 EUDAMED
07640452461665 EUDAMED
07640452461962 EUDAMED
07640452461689 EUDAMED
07640452461801 EUDAMED
07640452461924 EUDAMED
Basic UDI-DI
7640142410401019R EUDAMED
EMDN Code
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

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

Edge Sequel Sapphire by FKG Dentaire Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
FKG Dentaire Sàrl
EUDAMED SRN
CH-MF-000017925
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (45)

  • EUDAMED bf6536e2-ad4c-4c8f-9dad-6f9433c1272a 61 fields · synced Sep 18, 2026
  • EUDAMED fd205795-9a64-4c9f-884d-adc76d8e7cd0 61 fields · synced May 11, 2026
  • EUDAMED 7f6e3871-445b-4c0c-9321-b4b8da6551b9 61 fields · synced May 16, 2026
  • EUDAMED c3ee4f76-f1d3-40e6-8e65-d88a2d685c3d 61 fields · synced May 16, 2026
  • EUDAMED 6e8bafa4-6653-4158-89bd-e919a221f573 61 fields · synced May 16, 2026
  • EUDAMED 59f83bec-0fe7-4d60-9649-cb76cd990cab 61 fields · synced May 16, 2026
  • EUDAMED 1219bcfe-7c1e-435a-b68d-d2ff7d32feb9 61 fields · synced May 17, 2026
  • EUDAMED ab63017b-f313-45e9-a4e5-71af0d69cac9 61 fields · synced May 17, 2026
  • EUDAMED cf232082-8da3-43f3-963d-a9059a80c5ec 61 fields · synced May 17, 2026
  • EUDAMED 855d37a5-3ae8-4003-aaa9-69d7a0d5ce42 61 fields · synced May 17, 2026
  • EUDAMED fac9b5de-b443-4374-a364-55c5a8d5f1d8 61 fields · synced May 17, 2026
  • EUDAMED c8bbf4b0-1648-422e-afdd-951faffa6a8f 61 fields · synced May 17, 2026
  • EUDAMED f33a74ca-6787-403a-852a-d71fa1c309c2 61 fields · synced May 17, 2026
  • EUDAMED e75f9710-d149-4113-9194-2918c02c43dd 61 fields · synced May 17, 2026
  • EUDAMED d324ff91-517a-48c8-a403-88e07ea25576 61 fields · synced May 17, 2026
  • EUDAMED 026993fe-72bb-4a87-b806-2acf0b3f0a13 61 fields · synced May 17, 2026
  • EUDAMED 9c63b9be-1d4d-4e9d-abf8-29288857516e 61 fields · synced May 17, 2026
  • EUDAMED 066416de-3fde-4f0e-9a6e-2c91bb55b66e 61 fields · synced May 17, 2026
  • EUDAMED 1bc0f060-5dbe-4548-adf7-9e5c6268f356 61 fields · synced May 17, 2026
  • EUDAMED 2df0dc79-ebe0-4eec-a082-737c63646e9b 61 fields · synced May 17, 2026
  • EUDAMED f75af18e-353a-44df-b862-0d0530ae8042 61 fields · synced May 17, 2026
  • EUDAMED 65e27921-4103-4782-b1f4-68c678ae2b1c 61 fields · synced May 17, 2026
  • EUDAMED dd9310bf-07ef-4cf6-814c-dea56f289206 61 fields · synced May 17, 2026
  • EUDAMED 052f44f2-ee3e-45c2-a45a-ea3a47460385 61 fields · synced May 18, 2026
  • EUDAMED 52306d58-9c70-4884-a861-ef1209255fa3 61 fields · synced May 18, 2026
  • EUDAMED 96e3bb4a-251b-421a-9741-c18423b2410a 61 fields · synced May 18, 2026
  • EUDAMED 3b8c4de2-247b-48ab-9a0b-7b717b3c414b 61 fields · synced May 18, 2026
  • EUDAMED 5484f112-c840-476a-a97f-7afe966726cd 61 fields · synced May 18, 2026
  • EUDAMED 91c9432b-faff-4deb-a4f0-0f0276c91d8e 61 fields · synced May 18, 2026
  • EUDAMED d495619d-6f74-4ef5-bab8-5a3a7dc414ad 61 fields · synced May 18, 2026
  • EUDAMED 2a487bd0-8f22-4d4a-8f21-11ab1fcda001 61 fields · synced May 18, 2026
  • EUDAMED b920b04d-fb58-4e34-b2d0-0844a6a9712e 61 fields · synced May 18, 2026
  • EUDAMED b1a66814-33a6-458d-8830-48ea6cd9dec5 61 fields · synced May 18, 2026
  • EUDAMED d84ca452-19d4-4d1f-b052-bed22a107e3b 61 fields · synced May 18, 2026
  • EUDAMED f7ab8398-67e6-4d35-bc80-19db934a8e2f 61 fields · synced May 18, 2026
  • EUDAMED 471e1716-e8b8-457a-a0d5-fd59f326e881 61 fields · synced May 18, 2026
  • EUDAMED 7f8154ea-c385-4d8b-ac6c-ad2e176dc045 61 fields · synced May 18, 2026
  • EUDAMED 1edc6242-268a-4fb1-991b-6ccd046bb0a0 61 fields · synced May 19, 2026
  • EUDAMED 08e4fb4d-b428-46b6-a32c-1263ea339770 61 fields · synced May 19, 2026
  • EUDAMED 68a2f249-cc19-4e6c-bdea-ead2bcb9ecbe 61 fields · synced May 19, 2026
  • EUDAMED 2211cfb1-7621-4b5f-9c64-0c8194b94e34 61 fields · synced May 19, 2026
  • EUDAMED 6a9b978b-2098-4755-9539-646b1eb29984 61 fields · synced May 19, 2026
  • EUDAMED 512ced87-f964-4cb6-8e98-22f0f39947b8 61 fields · synced May 19, 2026
  • EUDAMED 11352c0c-3bfb-4c02-9936-e5e40cd441c8 61 fields · synced May 19, 2026
  • EUDAMED 977b9355-cd67-47de-a51f-6db0c89c54e7 61 fields · synced May 19, 2026