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ZENEX PLUS Fixture
EUDAMEDClass IIb (EU MDR)
Ref ZPRW5511Ref ZPRW5007Ref ZPRM3511SRef ZPRW5011Ref ZPRR4015Ref ZPRW5010Ref ZPRR4507Ref ZPRR4511Ref ZPRW5015Ref ZPSW5515Ref ZPRM3511Ref ZPRR4011Ref ZPRW5515Ref ZPRR4508Ref ZPRR4007Ref ZPRM3515Ref ZPRM3513Ref ZPRM3510Ref ZPRM3508Ref ZPRW5008Ref ZPRW5013
Identity
- Trade Name
- ZENEX PLUS Fixture EUDAMED
- Device Name
- ZENEX PLUS Fixture EUDAMEDZENEX PLUS Fixture Set (Fixture + Cover Screw) EUDAMED
- Model / Reference
- ZPRW5511 EUDAMEDZPRW5007 EUDAMEDZPRM3511S EUDAMEDZPRW5011 EUDAMEDZPRR4015 EUDAMEDZPRW5010 EUDAMEDZPRR4507 EUDAMEDZPRR4511 EUDAMEDZPRW5015 EUDAMEDZPSW5515 EUDAMEDZPRM3511 EUDAMEDZPRR4011 EUDAMEDZPRW5515 EUDAMEDZPRR4508 EUDAMEDZPRR4007 EUDAMEDZPRM3515 EUDAMEDZPRM3513 EUDAMEDZPRM3510 EUDAMEDZPRM3508 EUDAMEDZPRW5008 EUDAMEDZPRW5013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070203675 EUDAMED08800070203583 EUDAMED08800070230015 EUDAMED08800070203613 EUDAMED08800070203514 EUDAMED08800070203606 EUDAMED08800070203521 EUDAMED08800070203552 EUDAMED08800070203637 EUDAMED08800070202258 EUDAMED08800070203439 EUDAMED08800070203491 EUDAMED08800070203699 EUDAMED08800070203538 EUDAMED08800070203460 EUDAMED08800070203453 EUDAMED08800070203446 EUDAMED08800070203422 EUDAMED08800070203415 EUDAMED08800070203590 EUDAMED08800070203620 EUDAMED
- Basic UDI-DI
- B-08800070203675 EUDAMEDB-08800070203583 EUDAMEDB-08800070230015 EUDAMEDB-08800070203613 EUDAMEDB-08800070203514 EUDAMEDB-08800070203606 EUDAMEDB-08800070203521 EUDAMEDB-08800070203552 EUDAMEDB-08800070203637 EUDAMEDB-08800070202258 EUDAMEDB-08800070203439 EUDAMEDB-08800070203491 EUDAMEDB-08800070203699 EUDAMEDB-08800070203538 EUDAMEDB-08800070203460 EUDAMEDB-08800070203453 EUDAMEDB-08800070203446 EUDAMEDB-08800070203422 EUDAMEDB-08800070203415 EUDAMEDB-08800070203590 EUDAMEDB-08800070203620 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 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-08800070203675 | 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 (21)
- EUDAMED 829e91da-73cd-4851-8c54-6d790673bbec 61 fields · synced Sep 18, 2026
- EUDAMED 0d24f55e-220c-44b7-b1dd-a999121b0be8 61 fields · synced May 11, 2026
- EUDAMED 38b38bef-8852-42f8-9162-5ed52776bae0 61 fields · synced May 16, 2026
- EUDAMED f1fae624-ba83-4a75-acd4-85ac8d80abef 61 fields · synced May 16, 2026
- EUDAMED 8fadc5d7-0c03-48be-8a17-8e1bbe4a9c1b 61 fields · synced May 16, 2026
- EUDAMED 45aa90a8-220c-43ea-9d66-bf739a3ff3ef 61 fields · synced May 16, 2026
- EUDAMED a7537165-2770-4766-9293-789c2c1fef33 61 fields · synced May 16, 2026
- EUDAMED 53fc25eb-c0e9-4469-bf05-432345ad072f 61 fields · synced May 17, 2026
- EUDAMED 358815cd-8f3d-41b2-8ad5-5a6c0406cccd 61 fields · synced May 17, 2026
- EUDAMED 37f02da9-2c03-4f9d-97a2-f37cd8eedbfd 61 fields · synced May 17, 2026
- EUDAMED bce5ab54-e618-40a8-9dc1-f7b779f53306 61 fields · synced May 17, 2026
- EUDAMED fb91f25a-9c2b-475b-82b4-9c2ee14c8588 61 fields · synced May 18, 2026
- EUDAMED 8393a6d7-7e7c-401c-b53a-58f055479533 61 fields · synced May 18, 2026
- EUDAMED fa750327-11ae-41d6-b47b-840ffdf7b000 61 fields · synced May 18, 2026
- EUDAMED ca5681d9-7b92-44ca-8036-277c61a03720 61 fields · synced May 18, 2026
- EUDAMED df177ebf-eb18-48ee-85ec-4597e40e61b0 61 fields · synced May 18, 2026
- EUDAMED d117a850-358b-422a-bd92-b6d92969d392 61 fields · synced May 18, 2026
- EUDAMED 312a71a9-1aa9-445d-b8c3-56fc72b4ae8d 61 fields · synced May 18, 2026
- EUDAMED 1706f526-823f-4d47-8274-df7ac0f59394 61 fields · synced May 18, 2026
- EUDAMED 1de21051-bc49-46a9-a6da-860b47e20a7b 61 fields · synced May 18, 2026
- EUDAMED 0a7df1f7-8374-4b46-a9c3-9149db4146a9 61 fields · synced May 18, 2026