← Back to catalogue
Dental Fixture
EUDAMEDClass IIb (EU MDR)
Ref BT5008Ref BT3513Ref BT4511Ref BT3511Ref BT5510Ref BT5511Ref BT5515Ref BT5508Ref BT3510Ref BT5513Ref BT4015Ref BT4515Ref BT6010Ref BT5011Ref BT4508Ref BT6013Ref BT6011Ref BT4008Ref BT4513
by Kuwotech
Identity
- Trade Name
- Dental Fixture EUDAMED
- Model / Reference
- BT5008 EUDAMEDBT3513 EUDAMEDBT4511 EUDAMEDBT3511 EUDAMEDBT5510 EUDAMEDBT5511 EUDAMEDBT5515 EUDAMEDBT5508 EUDAMEDBT3510 EUDAMEDBT5513 EUDAMEDBT4015 EUDAMEDBT4515 EUDAMEDBT6010 EUDAMEDBT5011 EUDAMEDBT4508 EUDAMEDBT6013 EUDAMEDBT6011 EUDAMEDBT4008 EUDAMEDBT4513 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800034102181 EUDAMED08800034100040 EUDAMED08800034100170 EUDAMED08800034100033 EUDAMED08800034100316 EUDAMED08800034100323 EUDAMED08800034100347 EUDAMED08800034100309 EUDAMED08800034100026 EUDAMED08800034100330 EUDAMED08800034100118 EUDAMED08800034100194 EUDAMED08800034100392 EUDAMED08800034100248 EUDAMED08800034100156 EUDAMED08800034100415 EUDAMED08800034100408 EUDAMED08800034100071 EUDAMED08800034100187 EUDAMED
- Basic UDI-DI
- B-08800034102181 EUDAMEDB-08800034100040 EUDAMEDB-08800034100170 EUDAMEDB-08800034100033 EUDAMEDB-08800034100316 EUDAMEDB-08800034100323 EUDAMEDB-08800034100347 EUDAMEDB-08800034100309 EUDAMEDB-08800034100026 EUDAMEDB-08800034100330 EUDAMEDB-08800034100118 EUDAMEDB-08800034100194 EUDAMEDB-08800034100392 EUDAMEDB-08800034100248 EUDAMEDB-08800034100156 EUDAMEDB-08800034100415 EUDAMEDB-08800034100408 EUDAMEDB-08800034100071 EUDAMEDB-08800034100187 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Dental Fixture by Kuwotech — 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-08800034102181 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kuwotech
- EUDAMED SRN
- KR-MF-000037478
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (19)
- EUDAMED 310d4e03-f99d-4883-8939-ad33609c36b9 61 fields · synced Aug 4, 2026
- EUDAMED 1c95127d-b2c9-4c82-9aa4-7a53b09cac10 61 fields · synced May 16, 2026
- EUDAMED 24eb49f3-7178-47ad-9c37-4ac6d25824da 61 fields · synced May 16, 2026
- EUDAMED 251abaf0-33e4-4fdc-ab08-009c7846c951 61 fields · synced May 17, 2026
- EUDAMED 05cf18f7-78c5-4799-a70c-5fb87e130645 61 fields · synced May 17, 2026
- EUDAMED 69b8f51c-b6d5-49a7-b7ce-14a73a43fa57 61 fields · synced May 17, 2026
- EUDAMED 6a573cf7-8009-4ca4-b95d-8ae923f3c3b2 61 fields · synced May 17, 2026
- EUDAMED 753f291d-0a56-4e94-b4e1-c734f9f43720 61 fields · synced May 17, 2026
- EUDAMED a2d5330f-7afd-4144-9375-0fea82b80667 61 fields · synced May 17, 2026
- EUDAMED db5da270-e49a-4913-a484-7f77b136ff56 61 fields · synced May 18, 2026
- EUDAMED 2e1caa3b-9b22-40fd-8dc8-736ba2ef8962 61 fields · synced May 18, 2026
- EUDAMED 428fe7eb-7c45-4e1a-b3eb-c3bb8e5c5fb6 61 fields · synced May 18, 2026
- EUDAMED 41926eae-ff91-4982-b098-fbf71e74a7c8 61 fields · synced May 18, 2026
- EUDAMED 9403ec5d-7347-4de7-a6c8-52605dc67ad3 61 fields · synced May 18, 2026
- EUDAMED f26cf5f5-e7d2-4f16-a444-64d617e702a6 61 fields · synced May 18, 2026
- EUDAMED 9cdbe16c-f565-494d-ab58-f9789f833574 61 fields · synced May 18, 2026
- EUDAMED a0b4504f-72e1-4b76-8f2c-93f4dd3d6449 61 fields · synced May 19, 2026
- EUDAMED a4e9cd7c-3e50-473f-9c86-3bf6744ec8f0 61 fields · synced May 19, 2026
- EUDAMED 9f1b04be-53f4-4b19-89fa-5ff44f2507dc 61 fields · synced May 19, 2026