Implant Inserter

EUDAMED

Class I (EU MDR)

Ref 03.820.210Model Reusable instrumentation

by Centinel Spine, LLC

Identity

Trade Name: Implant Inserter EUDAMED
Model / Reference: Reusable instrumentation EUDAMED
03.820.210 EUDAMED

Identifiers

Primary DI / UDI-DI: 00843193116079 EUDAMED
Basic UDI-DI: 08431931InstrumentsU5 EUDAMED
EMDN Code: L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Orthopaedic implant impactor, reusable

Implant Inserter by Centinel Spine, LLC — Class I — 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	08431931InstrumentsU5	Class I	Active

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Manufacturer

Manufacturer: Centinel Spine, LLC
EUDAMED SRN: US-MF-000013245
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (1)

EUDAMED c07bbcc9-1247-4b02-a1f8-789807fb5311 61 fields · synced Jul 27, 2026