8801320 NDI Sterile Passive Spheres +2 more models

EUDAMED

Class I (EU MDR)

Ref 8801320x

by Northern Digital Inc.

Identity

Device Name: 8801320 NDI Sterile Passive Spheres; 10 spheres per tray; 2 trays per box. Total 20 spheres per box EUDAMED
Model / Reference: 8801320x EUDAMED

Identifiers

Primary DI / UDI-DI: D-880132023 EUDAMED
Basic UDI-DI: B-880132023 EUDAMED
EMDN Code: Z12130485 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Models / Variants: 8801320 NDI Sterile Passive Spheres EUDAMED
10 spheres per tray EUDAMED
2 trays per box. Total 20 spheres per box EUDAMED

Classification

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

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

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

8801320 NDI Sterile Passive Spheres +2 more models by Northern Digital Inc — Class I — MDD — listed in EUDAMED — 3 models — 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-880132023	Class I	Active

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Manufacturer

Manufacturer: Northern Digital Inc.
EUDAMED SRN: CA-MF-000023503
Authorised Representative: NDI Europe GmbH DE-AR-000019156

Sources (1)

EUDAMED d67bed38-522a-4fb7-adcc-c5cbb6a80570 61 fields · synced Jul 23, 2026