FWS-007A(II) Bone Cement Syringe ϕ20.0×105

EUDAMED

Class IIa (EU MDR)

Ref -Model FWS-007A(II) Bone Cement Syringe ϕ20.0×105 (sterile)

by Chongqing FWS Medical Device Co., Ltd

Identity

Trade Name: FWS-007A(II) Bone Cement Syringe ϕ20.0×105 EUDAMED
Device Name: Vertebroplasty auxiliary instrument EUDAMED
Model / Reference: FWS-007A(II) Bone Cement Syringe ϕ20.0×105 (sterile) EUDAMED
- EUDAMED

Identifiers

Primary DI / UDI-DI: D-007A(II)/BCSRS EUDAMED
Basic UDI-DI: B-007A(II)/BCSRS EUDAMED
EMDN Code: P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

FWS-007A(II) Bone Cement Syringe ϕ20.0×105 by Chongqing FWS Medical Device Co., Ltd — Class IIa — 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-007A(II)/BCSRS	Class IIa	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 a9dcd1e8-538f-4385-bfd4-c09ba1b1fa73 61 fields · synced Jul 11, 2026