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ActivaScrew™
EUDAMEDClass III (EU MDR)
Ref B-AS-2720Ref B-AL-3545Ref B-ALC-4065Ref B-AS-4535Ref B-ASC-3540Ref B-ALC-4070Ref B-ALC-4055Ref B-AS-3550Ref B-ASC-4070Ref B-AS-4560Ref B-ALC-4565Ref B-AL-3524Model B-AL-3520Ref B-AS-3516Ref B-ASC-3524Ref B-ALC-4555Ref B-AS-4540Ref B-ALC-3530Ref B-ASC-4050Ref B-AS-2714Ref B-ALC-4050Ref B-ASC-4560Ref B-AL-4570Ref B-AL-4535Ref B-ALC-3535Ref B-AS-2020Ref B-ALC-4060Ref B-ALC-4570Ref B-ALC-3524Ref B-AL-4540Ref B-ALC-4090Ref B-ALC-4550Ref B-ALC-4590Ref B-AS-3520Ref B-AS-2716Ref B-AS-3524Ref B-AL-4560Ref B-ASC-3532Ref B-ASC-4035Ref B-ALC-4035Ref B-ALC-4580Ref B-AS-4545Ref B-ASC-4540Ref B-ASC-3528Ref B-ASC-4045
Identity
- Trade Name
- ActivaScrew™ EUDAMEDActivaScrew™ Cannulated LAG EUDAMEDActivaScrew™ Cannulated EUDAMED
- Device Name
- ActivaScrew™ 2.7 x 20 mm EUDAMEDActivaScrew™ LAG 3.5 x 45 mm, thread 15 mm EUDAMEDActivaScrew™ Cannulated LAG 4.0 x 65 mm, thread 30 mm EUDAMEDActivaScrew™ 4.5 x 35 mm EUDAMEDActivaScrew™ Cannulated 3.5 x 40 mm EUDAMEDActivaScrew™ Cannulated LAG 4.0 x 70 mm, thread 32 mm EUDAMEDActivaScrew™ Cannulated LAG 4.0 x 55 mm, thread 26 mm EUDAMEDActivaScrew™ 3.5 x 50 mm EUDAMEDActivaScrew™ Cannulated 4.0 x 70 mm EUDAMEDActivaScrew™ 4.5 x 60 mm EUDAMEDActivaScrew™ Cannulated LAG 4.5 x 65 mm, thread 30 mm EUDAMEDActivaScrew™ LAG 3.5 x 20 mm, thread 8 mm EUDAMEDActivaScrew™ 3.5 x 16 mm EUDAMEDActivaScrew™ Cannulated 3.5 x 24 mm EUDAMEDActivaScrew™ Cannulated LAG 4.5 x 55 mm, thread 26 mm EUDAMEDActivaScrew™ 4.5 x 40 mm EUDAMEDActivaScrew™ Cannulated LAG 3.5 x 30 mm, thread 14 mm EUDAMEDActivaScrew™ Cannulated 4.0 x 50 mm EUDAMEDActivaScrew™ 2.7 x 14 mm EUDAMEDActivaScrew™ Cannulated LAG 4.0 x 50 mm, thread 24 mm EUDAMEDActivaScrew™ Cannulated 4.5 x 60 mm EUDAMEDActivaScrew™ LAG 4.5 x 70 mm, thread 32 mm EUDAMEDActivaScrew™ LAG 4.5 x 35 mm, thread 18 mm EUDAMEDActivaScrew™ Cannulated LAG 3.5 x 35 mm, thread 14 mm EUDAMEDActivaScrew™ 2.0 x 20 mm EUDAMEDActivaScrew™ Cannulated LAG 4.0 x 60 mm, thread 28 mm EUDAMEDActivaScrew™ Cannulated LAG 4.5 x 70 mm, thread 32 mm EUDAMEDActivaScrew™ Cannulated LAG 3.5 x 24 mm, thread 10 mm EUDAMEDActivaScrew™ LAG 4.5 x 40 mm, thread 20 mm EUDAMEDActivaScrew™ Cannulated LAG 4.0 x 90 mm, thread 46 mm EUDAMEDActivaScrew™ Cannulated LAG 4.5 x 50 mm, thread 24 mm EUDAMEDActivaScrew™ Cannulated LAG 4.5 x 90 mm, thread 46 mm EUDAMEDActivaScrew™ 3.5 x 20 mm EUDAMEDActivaScrew™ 2.7 x 16 mm EUDAMEDActivaScrew™ 3.5 x 24 mm EUDAMEDActivaScrew™ LAG 4.5 x 60 mm, thread 28 mm EUDAMEDActivaScrew™ Cannulated 3.5 x 32 mm EUDAMEDActivaScrew™ Cannulated 4.0 x 35 mm EUDAMEDActivaScrew™ Cannulated LAG 4.0 x 35 mm, thread 18 mm EUDAMEDActivaScrew™ Cannulated LAG 4.5 x 80 mm, thread 40 mm EUDAMEDActivaScrew™ 4.5 x 45 mm EUDAMEDActivaScrew™ Cannulated 4.5 x 40 mm EUDAMEDActivaScrew™ Cannulated 3.5 x 28 mm EUDAMEDActivaScrew™ Cannulated 4.0 x 45 mm EUDAMED
- Model / Reference
- B-AS-2720 EUDAMEDB-AL-3545 EUDAMEDB-ALC-4065 EUDAMEDB-AS-4535 EUDAMEDB-ASC-3540 EUDAMEDB-ALC-4070 EUDAMEDB-ALC-4055 EUDAMEDB-AS-3550 EUDAMEDB-ASC-4070 EUDAMEDB-AS-4560 EUDAMEDB-ALC-4565 EUDAMEDB-AL-3520 EUDAMEDB-AL-3524 EUDAMEDB-AS-3516 EUDAMEDB-ASC-3524 EUDAMEDB-ALC-4555 EUDAMEDB-AS-4540 EUDAMEDB-ALC-3530 EUDAMEDB-ASC-4050 EUDAMEDB-AS-2714 EUDAMEDB-ALC-4050 EUDAMEDB-ASC-4560 EUDAMEDB-AL-4570 EUDAMEDB-AL-4535 EUDAMEDB-ALC-3535 EUDAMEDB-AS-2020 EUDAMEDB-ALC-4060 EUDAMEDB-ALC-4570 EUDAMEDB-ALC-3524 EUDAMEDB-AL-4540 EUDAMEDB-ALC-4090 EUDAMEDB-ALC-4550 EUDAMEDB-ALC-4590 EUDAMEDB-AS-3520 EUDAMEDB-AS-2716 EUDAMEDB-AS-3524 EUDAMEDB-AL-4560 EUDAMEDB-ASC-3532 EUDAMEDB-ASC-4035 EUDAMEDB-ALC-4035 EUDAMEDB-ALC-4580 EUDAMEDB-AS-4545 EUDAMEDB-ASC-4540 EUDAMEDB-ASC-3528 EUDAMEDB-ASC-4045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394000551 EUDAMED06438394001046 EUDAMED06438394004894 EUDAMED06438394000698 EUDAMED06438394001640 EUDAMED06438394004900 EUDAMED06438394004870 EUDAMED06438394008915 EUDAMED06438394004771 EUDAMED06438394000742 EUDAMED06438394002029 EUDAMED06438394000964 EUDAMED06438394000599 EUDAMED06438394001602 EUDAMED06438394002005 EUDAMED06438394000704 EUDAMED06438394005860 EUDAMED06438394004733 EUDAMED06438394000520 EUDAMED06438394004863 EUDAMED06438394001718 EUDAMED06438394001145 EUDAMED06438394001077 EUDAMED06438394005877 EUDAMED06438394000490 EUDAMED06438394004887 EUDAMED06438394002036 EUDAMED06438394001909 EUDAMED06438394001084 EUDAMED06438394004924 EUDAMED06438394001992 EUDAMED06438394002050 EUDAMED06438394000612 EUDAMED06438394000537 EUDAMED06438394000629 EUDAMED06438394001121 EUDAMED06438394001626 EUDAMED06438394004702 EUDAMED06438394004832 EUDAMED06438394002043 EUDAMED06438394000711 EUDAMED06438394001671 EUDAMED06438394001619 EUDAMED06438394004726 EUDAMED
- Basic UDI-DI
- B-06438394000551 EUDAMEDB-06438394001046 EUDAMEDB-06438394004894 EUDAMEDB-06438394000698 EUDAMEDB-06438394001640 EUDAMEDB-06438394004900 EUDAMEDB-06438394004870 EUDAMEDB-06438394008915 EUDAMEDB-06438394004771 EUDAMEDB-06438394000742 EUDAMEDB-06438394002029 EUDAMEDB-06438394000964 EUDAMEDB-06438394000599 EUDAMEDB-06438394001602 EUDAMEDB-06438394002005 EUDAMEDB-06438394000704 EUDAMEDB-06438394005860 EUDAMEDB-06438394004733 EUDAMEDB-06438394000520 EUDAMEDB-06438394004863 EUDAMEDB-06438394001718 EUDAMEDB-06438394001145 EUDAMEDB-06438394001077 EUDAMEDB-06438394005877 EUDAMEDB-06438394000490 EUDAMEDB-06438394004887 EUDAMEDB-06438394002036 EUDAMEDB-06438394001909 EUDAMEDB-06438394001084 EUDAMEDB-06438394004924 EUDAMEDB-06438394001992 EUDAMEDB-06438394002050 EUDAMEDB-06438394000612 EUDAMEDB-06438394000537 EUDAMEDB-06438394000629 EUDAMEDB-06438394001121 EUDAMEDB-06438394001626 EUDAMEDB-06438394004702 EUDAMEDB-06438394004832 EUDAMEDB-06438394002043 EUDAMEDB-06438394000711 EUDAMEDB-06438394001671 EUDAMEDB-06438394001619 EUDAMEDB-06438394004726 EUDAMED
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
ActivaScrew™ by Bioretec Ltd. — Class III — 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-06438394000551 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (44)
- EUDAMED 68f6ce88-3ae5-40ac-8c38-760b68a95797 61 fields · synced Aug 4, 2026
- EUDAMED f5833f2b-76b1-4795-80b2-77917e7fb65f 61 fields · synced May 11, 2026
- EUDAMED 0a1a44fb-86dd-412a-995e-d318021fcca9 61 fields · synced May 16, 2026
- EUDAMED 72675e8e-20ab-4ff0-af20-f49a9ec99d23 61 fields · synced May 16, 2026
- EUDAMED c4529e2a-2687-45ad-be2b-ca22939fe1f7 61 fields · synced May 16, 2026
- EUDAMED 9c0be7a9-54d1-4b7f-9dce-f9f0d7ac844c 61 fields · synced May 16, 2026
- EUDAMED e069b648-51e9-49b9-95ea-c79990f127c2 61 fields · synced May 16, 2026
- EUDAMED ff6689d4-1734-470e-b3dc-ce5fb91abac1 61 fields · synced May 16, 2026
- EUDAMED 12a10976-f6b8-4068-80bf-e07242c486a7 61 fields · synced May 16, 2026
- EUDAMED 1378364a-4944-485e-b564-194402773aea 61 fields · synced May 17, 2026
- EUDAMED 4ac1b4de-5266-4c26-8789-781b198e4c52 61 fields · synced May 17, 2026
- EUDAMED c322f185-6725-45d5-bc41-0811e8eecc99 61 fields · synced May 17, 2026
- EUDAMED a2a85707-d56e-4230-99ab-d82be8682df6 61 fields · synced May 17, 2026
- EUDAMED b6ae2c3d-ee00-459e-aba8-c7abe6812e73 61 fields · synced May 17, 2026
- EUDAMED c6691df0-5306-4b36-b60b-2a728b3b66f4 61 fields · synced May 17, 2026
- EUDAMED c3491821-2d60-4c43-b492-337737ad324e 61 fields · synced May 17, 2026
- EUDAMED b9c4e12e-899b-4b93-af99-c1365d9bbc8e 61 fields · synced May 17, 2026
- EUDAMED 28868751-54f4-472a-84d4-a6cf3bdc7350 61 fields · synced May 17, 2026
- EUDAMED f738120a-a580-4c7c-a203-6f8f1e2684fd 61 fields · synced May 17, 2026
- EUDAMED 2158e4b5-3194-4525-95ab-c63df2a4c389 61 fields · synced May 17, 2026
- EUDAMED 9cfac736-d002-4508-b082-b2bc1f869736 61 fields · synced May 17, 2026
- EUDAMED fc7276c8-f8bd-4bc9-8cc9-64f125d5fd20 61 fields · synced May 17, 2026
- EUDAMED 86bde7b4-d915-4cb9-9a7f-7fcbfc25d2ff 61 fields · synced May 17, 2026
- EUDAMED 35ade3ac-7431-4775-bf5f-6788dd553fa8 61 fields · synced May 18, 2026
- EUDAMED aebb7704-8ddc-489e-8bd9-1df980c80e22 61 fields · synced May 18, 2026
- EUDAMED cee9dd7c-5252-4abc-9172-44ac891e948f 61 fields · synced May 18, 2026
- EUDAMED fdb4ac65-bde5-42a9-aae7-84ae3a4af33d 61 fields · synced May 18, 2026
- EUDAMED 7419061a-ae34-4d77-9ae3-c9a0479bd749 61 fields · synced May 18, 2026
- EUDAMED 7c8f14c2-cd2b-45fc-9382-e22cfe5b6419 61 fields · synced May 18, 2026
- EUDAMED bac205b8-90a1-405a-b381-9ce956a5a093 61 fields · synced May 18, 2026
- EUDAMED 1a837e49-34f9-45e7-a54d-daf7a7b777ec 61 fields · synced May 18, 2026
- EUDAMED c704a4f5-f685-4dab-90fc-3c44e3e1d589 61 fields · synced May 18, 2026
- EUDAMED 631473cd-5fcb-4415-9038-56d78fe4a13a 61 fields · synced May 18, 2026
- EUDAMED c58ac32a-e3d4-4943-a18f-35529b3388ea 61 fields · synced May 18, 2026
- EUDAMED 0edf343d-cbbf-48d8-9f77-6a5ca2bb05df 61 fields · synced May 18, 2026
- EUDAMED ee481e2e-1b24-4f84-924a-9cfa58ce8a08 61 fields · synced May 18, 2026
- EUDAMED 9082f721-77fc-4b52-986e-49d3202d0650 61 fields · synced May 18, 2026
- EUDAMED b5b184ae-afcf-4095-a9e9-4cf46801a1de 61 fields · synced May 18, 2026
- EUDAMED 089aaf6d-d2cd-4df6-927d-40b6cd291f34 61 fields · synced May 18, 2026
- EUDAMED 8f589203-855c-45ea-8cf5-fa5811787024 61 fields · synced May 19, 2026
- EUDAMED fb2a5b27-aa7c-4614-8823-d698a1dadcc5 61 fields · synced Jul 9, 2026
- EUDAMED 373baa67-2139-4d67-8179-fad135a98e45 61 fields · synced Jul 19, 2026
- EUDAMED 2475619e-b93d-4f70-9f44-6bcd0ae93722 61 fields · synced Jul 21, 2026
- EUDAMED 9ce63d3a-a5e1-411a-9544-ef52ed6a0bf0 61 fields · synced Jul 29, 2026