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Screw(Ⅰ), Self-drilling
EUDAMEDClass IIb (EU MDR)
Ref F15BB-PA00070Ref F15BB-PA00068Ref F15BB-PA00069
Identity
- Trade Name
- Screw(Ⅰ),Self-drilling EUDAMED
- Device Name
- Non-sterile Spinal Internal Fixation Systems EUDAMED
- Model / Reference
- F15BB-PA00070 EUDAMEDF15BB-PA00068 EUDAMEDF15BB-PA00069 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934635768391 EUDAMED06934635768377 EUDAMED06934635768384 EUDAMED
- Basic UDI-DI
- B-06934635768391 EUDAMEDB-06934635768377 EUDAMEDB-06934635768384 EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Category: Cervical spine immobilization system, single-use
Screw(Ⅰ), Self-drilling by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cervical spine immobilization system, single-use.
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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-06934635768391 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED a124f89f-2163-4026-9709-902b3bfa1c71 61 fields · synced Jul 28, 2026
- EUDAMED 8a8a6b0e-8c9e-4578-b6d0-2743f2c0ca7a 61 fields · synced May 18, 2026
- EUDAMED 7c05b501-af65-49b4-b8ea-974800647b50 61 fields · synced May 18, 2026