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SDP-79 Straight Locking Plate (4 hole) (sterile)
EUDAMEDClass IIb (EU MDR)
Ref N/AModel SDP-79 Straight Locking Plate (4 hole) (sterile)
Identity
- Trade Name
- SDP-79 Straight Locking Plate (4 hole) (sterile) EUDAMED
- Device Name
- Locking Plate EUDAMED
- Model / Reference
- SDP-79 Straight Locking Plate (4 hole) (sterile) EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SDP-79/04SU8 EUDAMED
- Basic UDI-DI
- B-SDP-79/04SU8 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Category: Orthopaedic fixation plate, non-bioabsorbable
SDP-79 Straight Locking Plate (4 hole) (sterile) by Chongqing FWS Medical Device Co., Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-SDP-79/04SU8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Chongqing FWS Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000008972
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED d6e26be8-ed82-433f-a1b9-b36af5703417 61 fields · synced Jul 21, 2026