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Zendura
EUDAMEDClass I (EU MDR)
Ref 9313Ref 9307Ref 9192Ref 9265Ref 9287-20Ref 9312Ref 9318Ref 9170-20Ref 9232-20Ref 9321Ref 9231-20Ref 9169-20Ref 9191Ref 9295Ref 9171-20Ref 9204-20Ref 9156-20Ref 9319Ref 9277Ref 9212-20Ref 9164-20Ref 9190-20Ref 9206-20Ref 9316Ref 9251Ref 9315Ref 9155Ref 9163-20Ref 9207
Identity
- Trade Name
- Zendura EUDAMED
- Device Name
- Zendura TRAK EUDAMEDZendura A EUDAMEDZendura FLX and Zendura VIVA EUDAMEDZendura AT EUDAMED
- Model / Reference
- 9313 EUDAMED9307 EUDAMED9192 EUDAMED9265 EUDAMED9287-20 EUDAMED9312 EUDAMED9318 EUDAMED9170-20 EUDAMED9232-20 EUDAMED9321 EUDAMED9231-20 EUDAMED9169-20 EUDAMED9191 EUDAMED9295 EUDAMED9171-20 EUDAMED9204-20 EUDAMED9156-20 EUDAMED9319 EUDAMED9277 EUDAMED9212-20 EUDAMED9164-20 EUDAMED9190-20 EUDAMED9206-20 EUDAMED9316 EUDAMED9251 EUDAMED9315 EUDAMED9155 EUDAMED9163-20 EUDAMED9207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850016682628 EUDAMED00850016682512 EUDAMED00850016682253 EUDAMED00850016682215 EUDAMED00850016682475 EUDAMED00850016682437 EUDAMED00850016682581 EUDAMED00850016682529 EUDAMED00850016682451 EUDAMED00850016682659 EUDAMED00850016682154 EUDAMED00850016682130 EUDAMED00850016682246 EUDAMED00850016682383 EUDAMED00850016682536 EUDAMED00850016682147 EUDAMED00850016682031 EUDAMED00850016682635 EUDAMED00850016682505 EUDAMED00850016682444 EUDAMED00850016682079 EUDAMED00850016682093 EUDAMED00850016682116 EUDAMED00850016682567 EUDAMED00850016682345 EUDAMED00850016682550 EUDAMED00850016682161 EUDAMED00850016682055 EUDAMED00850016682277 EUDAMED
- Basic UDI-DI
- 08500166820004G9 EUDAMED08500166820001G3 EUDAMED08500166820003G7 EUDAMED08500166820002G5 EUDAMED
- Unit of Use DI
- 00850016682291 EUDAMED00850016682338 EUDAMED00850016682024 EUDAMED00850016682123 EUDAMED00850016682314 EUDAMED00850016682017 EUDAMED00850016682000 EUDAMED00850016682321 EUDAMED00850016682062 EUDAMED00850016682086 EUDAMED00850016682109 EUDAMED00850016682048 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Zendura by Bay Materials LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 08500166820004G9 | Class I | Active |
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Manufacturer
- Manufacturer
- Bay Materials LLC
- EUDAMED SRN
- US-MF-000049150
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (29)
- EUDAMED f5da3bcd-f6da-4d75-a5d2-8547abef70b6 61 fields · synced Aug 4, 2026
- EUDAMED 05cc5d8d-59d9-42b4-830a-d6b683bc6b1a 61 fields · synced May 11, 2026
- EUDAMED 142ccff0-9987-4b06-b052-3773e139c10c 61 fields · synced May 11, 2026
- EUDAMED 3b927688-8efb-436e-a63d-d604648bb711 61 fields · synced May 16, 2026
- EUDAMED 6d3844dd-d0fd-4f60-82b9-b6590da1b9dc 61 fields · synced May 16, 2026
- EUDAMED a9db3342-d309-4db8-b314-a7f07173a390 61 fields · synced May 16, 2026
- EUDAMED 5dd67c03-178b-4790-9c28-6714ab589472 61 fields · synced May 17, 2026
- EUDAMED 8e647b8d-c088-4497-bffd-a3160e9e1674 61 fields · synced May 17, 2026
- EUDAMED bcf7e6dc-ee4b-44b1-aa2c-7d71d7aed91f 61 fields · synced May 17, 2026
- EUDAMED b09f7676-87cd-409f-a319-e0a779d6540a 61 fields · synced May 17, 2026
- EUDAMED 0b132fd3-b62e-495f-8424-05f7d5654d72 61 fields · synced May 17, 2026
- EUDAMED fbb53dc0-f949-439d-b668-e34b61719bc9 61 fields · synced May 17, 2026
- EUDAMED f609c14f-7260-4f90-9c59-e4e83e708c88 61 fields · synced May 17, 2026
- EUDAMED 60eeff12-23cf-4edc-a1b4-69b9926c9f11 61 fields · synced May 17, 2026
- EUDAMED 47fa2092-8aaf-4323-be9f-553b2fb0387f 61 fields · synced May 17, 2026
- EUDAMED 0e9a987b-f8e5-47f7-a6ae-44c4f6b71c6a 61 fields · synced May 17, 2026
- EUDAMED 9b606ebf-ecab-4c18-8cfb-3c243677e2a1 61 fields · synced May 18, 2026
- EUDAMED 4b885579-ee95-4ec9-a39b-084e09ec627c 61 fields · synced May 18, 2026
- EUDAMED 3fec007a-89e4-4c88-8e55-d6b8894aefd5 61 fields · synced May 18, 2026
- EUDAMED c4378970-a905-45c3-a273-7fb1bdc655df 61 fields · synced May 18, 2026
- EUDAMED ed0e4dfe-8c2b-4ba9-909b-c6e8c512b880 61 fields · synced May 18, 2026
- EUDAMED 72ffe608-7a39-4545-89c4-d8dd6137867a 61 fields · synced May 18, 2026
- EUDAMED fab8fcca-f52e-4beb-ab16-a887343bbf7a 61 fields · synced May 18, 2026
- EUDAMED 6d0dc885-d2d0-4ffb-be80-ca40d5a7cc9f 61 fields · synced May 18, 2026
- EUDAMED 93626627-90ea-477c-bfd3-d48f72bbe3ea 61 fields · synced May 18, 2026
- EUDAMED 730689ec-ab9b-4e8d-b6fa-1da2b4aeeaa0 61 fields · synced May 18, 2026
- EUDAMED 344b1c20-cb39-4db8-8ba8-e99e04b79805 61 fields · synced May 18, 2026
- EUDAMED 93a095d8-5c06-4703-bb9e-c6e9983b13dd 61 fields · synced May 19, 2026
- EUDAMED 4e4f4861-1e02-4cdd-a2fd-00501877b0b8 61 fields · synced May 19, 2026