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Screwfix
EUDAMEDClass IIa (EU MDR)
Ref SF132002CDRef SF0920.503M1DRef SF1118.501C1DRef SF092512C1DRef SF092103DRef SF112601DRef KKSF092408Ref SF092514B1BRef SF121210-SPRef 739099Ref SF0927.302S1DRef SF092708C1Ref SF0921.2071DRef SF092708C1D
Identity
- Trade Name
- SCREWFIX EUDAMED
- Device Name
- CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY EUDAMEDSCREWFIX EUDAMED
- Model / Reference
- SF132002CD EUDAMEDSF0920.503M1D EUDAMEDSF1118.501C1D EUDAMEDSF092512C1D EUDAMEDSF092103D EUDAMEDSF112601D EUDAMEDKKSF092408 EUDAMEDSF092514B1B EUDAMEDSF121210-SP EUDAMED739099 EUDAMEDSF0927.302S1D EUDAMEDSF092708C1 EUDAMEDSF0921.2071D EUDAMEDSF092708C1D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860043346 EUDAMED08033860027407 EUDAMED08033860025519 EUDAMED08033860035365 EUDAMED08033860034542 EUDAMED08033860038274 EUDAMED08033860039837 EUDAMED08033860037581 EUDAMED08033860030780 EUDAMED08033860038861 EUDAMED08033860018047 EUDAMED08033860018269 EUDAMED08033860029272 EUDAMED08033860027391 EUDAMED
- Basic UDI-DI
- 8033860SFFT01CU2 EUDAMEDB-08033860035365 EUDAMEDB-08033860039837 EUDAMEDB-08033860038274 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Screwfix by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860SFFT01CU2 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860SFFT01CU2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (17)
- EUDAMED 08490d54-ef16-4a4d-87f5-f44f09f9e2cb 61 fields · synced Jul 28, 2026
- EUDAMED b05a3bc5-d36c-4bad-a726-217cc95decd3 61 fields · synced May 16, 2026
- EUDAMED 78c7ea4c-0d19-4eda-9533-fbe5aa753fcc 61 fields · synced May 16, 2026
- EUDAMED 2ea99f43-1d86-47c2-8ba3-34ea23e6be24 61 fields · synced May 17, 2026
- EUDAMED 551d1f07-7c3d-4515-8d11-cb54b0788497 61 fields · synced May 17, 2026
- EUDAMED 90ebb0b0-da0f-40e3-9b46-e1e68da6a89f 61 fields · synced May 17, 2026
- EUDAMED 06bdea45-1e8e-4281-a58b-2b167571a681 61 fields · synced May 17, 2026
- EUDAMED 7a1b5d1f-bc08-4ef4-ba7d-8f2e6a8ac9e5 61 fields · synced May 18, 2026
- EUDAMED fcc09726-80fd-44a9-a7f2-e31c22a1766d 61 fields · synced May 18, 2026
- EUDAMED 108a945b-c5e2-46a9-bb62-c297cfea880f 61 fields · synced May 18, 2026
- EUDAMED a281ff02-b19f-4108-b085-fa3a015eeb4c 61 fields · synced May 18, 2026
- EUDAMED ddac566a-1f42-4e39-b51c-c01392c70a07 61 fields · synced May 18, 2026
- EUDAMED d20be0a2-4a01-4290-b5af-188e7c26fd4e 61 fields · synced May 18, 2026
- EUDAMED 9b6ca420-dda1-4d4c-a946-568260fcc430 61 fields · synced May 19, 2026
- EUDAMED 3559ae58-d6b8-4f1d-8a8e-8308efe2b25d 61 fields · synced Jul 13, 2026
- EUDAMED 6b96951d-50a7-4d8e-b7b5-6718124e3bba 61 fields · synced Jul 17, 2026
- EUDAMED 3f9bf1e3-5347-4a66-a053-7e3338a6139d 61 fields · synced Jul 22, 2026