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ZENEX PLUS Fixture Set
EUDAMEDClass IIb (EU MDR)
Ref ZPRR4510SRef ZPRW5507SRef ZPRW5011SRef ZPRM3513SRef ZPRM3515SRef ZPSW5515SRef ZPRM3508SRef ZPRR4007SRef ZPRR4010SRef ZPRR4008SRef ZPRW5515SRef ZPRW5015SRef ZPRW5007SRef ZPSR4520SRef ZPRR4513SRef ZPRW5513SRef ZPRW5511SRef ZPRM3510SRef ZPRR4508S
Identity
- Trade Name
- ZENEX PLUS Fixture Set EUDAMED
- Device Name
- ZENEX PLUS Fixture Set (Fixture + Cover Screw) EUDAMEDZENEX MULTI Fixture EUDAMED
- Model / Reference
- ZPRR4510S EUDAMEDZPRW5507S EUDAMEDZPRW5011S EUDAMEDZPRM3513S EUDAMEDZPRM3515S EUDAMEDZPSW5515S EUDAMEDZPRM3508S EUDAMEDZPRR4007S EUDAMEDZPRR4010S EUDAMEDZPRR4008S EUDAMEDZPRW5515S EUDAMEDZPRW5015S EUDAMEDZPRW5007S EUDAMEDZPSR4520S EUDAMEDZPRR4513S EUDAMEDZPRW5513S EUDAMEDZPRW5511S EUDAMEDZPRM3510S EUDAMEDZPRR4508S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070230121 EUDAMED08800070230220 EUDAMED08800070230190 EUDAMED08800070230022 EUDAMED08800070230039 EUDAMED08800070229699 EUDAMED08800070229996 EUDAMED08800070230046 EUDAMED08800070230060 EUDAMED08800070230053 EUDAMED08800070230275 EUDAMED08800070230213 EUDAMED08800070230169 EUDAMED08800070229576 EUDAMED08800070230145 EUDAMED08800070230268 EUDAMED08800070230251 EUDAMED08800070230008 EUDAMED08800070230114 EUDAMED
- Basic UDI-DI
- B-08800070230121 EUDAMEDB-08800070230220 EUDAMEDB-08800070230190 EUDAMEDB-08800070230022 EUDAMEDB-08800070230039 EUDAMEDB-08800070229699 EUDAMEDB-08800070229996 EUDAMEDB-08800070230046 EUDAMEDB-08800070230060 EUDAMEDB-08800070230053 EUDAMEDB-08800070230275 EUDAMEDB-08800070230213 EUDAMEDB-08800070230169 EUDAMEDB-08800070229576 EUDAMEDB-08800070230145 EUDAMEDB-08800070230268 EUDAMEDB-08800070230251 EUDAMEDB-08800070230008 EUDAMEDB-08800070230114 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
ZENEX PLUS Fixture Set by Izenimplant Co., Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800070230121 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Izenimplant Co., Ltd
- EUDAMED SRN
- KR-MF-000026205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (19)
- EUDAMED efc9b6cd-d94f-4040-9087-0d08a6684398 61 fields · synced Sep 18, 2026
- EUDAMED bce5496b-d1cf-443d-9ba3-67d923d1c764 61 fields · synced May 16, 2026
- EUDAMED 4d05b609-0eef-4ecb-89e5-265508bb776b 61 fields · synced May 16, 2026
- EUDAMED d5dabafc-94ea-47a9-b42b-c632b9923b25 61 fields · synced May 17, 2026
- EUDAMED 22bafd66-bdd3-4192-baeb-356b393acd31 61 fields · synced May 17, 2026
- EUDAMED 2070ecdb-f70a-4479-9545-418fc3c14122 61 fields · synced May 17, 2026
- EUDAMED cc073f9a-479a-448f-9061-89acdf74a8a9 61 fields · synced May 18, 2026
- EUDAMED 69ab4804-297f-4e89-866e-0ed9db6d7fdc 61 fields · synced May 18, 2026
- EUDAMED 7b39c366-2f24-4d22-b4fb-706c6021e8fa 61 fields · synced May 18, 2026
- EUDAMED 542bff3d-a617-479a-b9c0-505d765d2747 61 fields · synced May 18, 2026
- EUDAMED 63a60eb4-8781-485f-a138-f207c69efdd7 61 fields · synced May 18, 2026
- EUDAMED 104def3f-3d07-4e17-9e2d-65cf84dc91db 61 fields · synced May 18, 2026
- EUDAMED ac67e9a2-c6fe-46cd-97bb-457307683bf5 61 fields · synced May 18, 2026
- EUDAMED e7c76556-36ae-48fd-9159-8c5f6e1dc1eb 61 fields · synced May 18, 2026
- EUDAMED 2608ce4f-1a15-4e85-a90e-6622a40f6973 61 fields · synced May 18, 2026
- EUDAMED 8a641a1c-0e5b-49c7-86e8-d35b4a246b2d 61 fields · synced May 18, 2026
- EUDAMED 2b656cba-68c5-4c73-8c67-c554b67c043f 61 fields · synced May 18, 2026
- EUDAMED fdda54b1-a647-4ddc-849a-2f9312fe73cf 61 fields · synced May 19, 2026
- EUDAMED db9c688a-dced-4e54-a4fc-4639888abad6 61 fields · synced May 19, 2026