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PCF Polyaxial Reduction Screw
EUDAMEDClass IIb (EU MDR)
Ref 802024048Model WGB1Z-4Ref 802023530Ref 802023536Ref 802024022Ref 802023532Ref 802023552Ref 802023512Ref 802024014Ref 802023534Ref 802023542Ref 802023510Ref 802023524Ref 802024012Ref 802024026Ref 802023518Ref 802023544Ref 802024010Ref 802024024Ref 802024038Ref 802024018Ref 802023528
Identity
- Trade Name
- PCF Polyaxial Reduction Screw EUDAMED
- Device Name
- Sterile and Non Sterile Spinal System EUDAMED
- Model / Reference
- WGB1Z-4 EUDAMED802024048 EUDAMED802023530 EUDAMED802023536 EUDAMED802024022 EUDAMED802023532 EUDAMED802023552 EUDAMED802023512 EUDAMED802024014 EUDAMED802023534 EUDAMED802023542 EUDAMED802023510 EUDAMED802023524 EUDAMED802024012 EUDAMED802024026 EUDAMED802023518 EUDAMED802023544 EUDAMED802024010 EUDAMED802024024 EUDAMED802024038 EUDAMED802024018 EUDAMED802023528 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06912547146209 EUDAMED06912547145899 EUDAMED06912547145929 EUDAMED06912547146070 EUDAMED06912547145905 EUDAMED06912547146001 EUDAMED06912547145806 EUDAMED06912547146032 EUDAMED06912547145912 EUDAMED06912547145950 EUDAMED06912547145790 EUDAMED06912547145868 EUDAMED06912547146025 EUDAMED06912547146094 EUDAMED06912547145837 EUDAMED06912547145967 EUDAMED06912547146018 EUDAMED06912547146087 EUDAMED06912547146155 EUDAMED06912547146056 EUDAMED06912547145882 EUDAMED
- Basic UDI-DI
- 6903095SPIWGB1Z4PR6S EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Category: Cervical spine immobilization system, single-use
PCF Polyaxial Reduction Screw by Shandong Weigao Orthopaedic Device Company Limited. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6903095SPIWGB1Z4PR6S | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Weigao Orthopaedic Device Company Limited.
- EUDAMED SRN
- CN-MF-000019785
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (21)
- EUDAMED 31e47f53-3695-4567-b873-daa0d9598ce1 61 fields · synced Aug 4, 2026
- EUDAMED b4a1f4cf-d0b4-4faf-9f50-15491e005217 61 fields · synced May 16, 2026
- EUDAMED fb19713a-aca4-4e45-aa6d-0b1a59b27e3c 61 fields · synced May 16, 2026
- EUDAMED 6b078a3f-2392-4894-9e86-0a5d3db88977 61 fields · synced May 16, 2026
- EUDAMED c3f4caf3-0b98-4f89-a453-8f69bf0da57d 61 fields · synced May 16, 2026
- EUDAMED 50cedb01-04b6-4066-8add-81b2edcd8395 61 fields · synced May 17, 2026
- EUDAMED 72df7393-e4f2-445f-ad28-320df29339fb 61 fields · synced May 17, 2026
- EUDAMED 918633e6-47a5-468d-baf0-5da84c08a6d5 61 fields · synced May 17, 2026
- EUDAMED 3a488d9d-3f1c-45d4-a64d-a471693b97b1 61 fields · synced May 17, 2026
- EUDAMED 8b729f4e-32e6-4aad-ab17-38199ca40565 61 fields · synced May 17, 2026
- EUDAMED 23bcdfb5-bf99-40d6-983a-4b7464a27915 61 fields · synced May 18, 2026
- EUDAMED c41c88fb-7bde-4dc4-81af-cdba3d29d0fc 61 fields · synced May 18, 2026
- EUDAMED 97aba17d-5b05-46d1-b26c-51bf47d19ebe 61 fields · synced May 18, 2026
- EUDAMED ae679187-182f-4337-a92d-07603ca850c7 61 fields · synced May 18, 2026
- EUDAMED 2688f1cb-add7-4ed5-9378-a06fb4336893 61 fields · synced May 18, 2026
- EUDAMED 5656daf2-f483-4bc2-90fd-ca90e979260c 61 fields · synced May 18, 2026
- EUDAMED 9e148a2e-4a2f-4480-9a47-33334d4f0df8 61 fields · synced May 18, 2026
- EUDAMED 8b011e4e-cf60-4bb7-acb3-210e00abac5c 61 fields · synced May 18, 2026
- EUDAMED 30d7a2a9-8d6c-43af-b26c-341c4913d4ba 61 fields · synced May 18, 2026
- EUDAMED ef999179-185f-42c8-a03d-3af4557d1894 61 fields · synced May 19, 2026
- EUDAMED 190b4c62-7674-4822-aa20-4f0d24eb8478 61 fields · synced May 19, 2026