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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

RDT00016 — Class IIa MDD by Paradigm Spine GmbH

MD Atlas
Paradigm Spine GmbH

EUDAMED last updated this device on May 21, 2026

RDT00016

B-04260148897986

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Paradigm Spine GmbH
UDI-DI code: 04260148897986
Reference / catalog number: RDT00016

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Manufacturer information

Organization name: Paradigm Spine GmbH
SRN: DE-MF-000011231
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Prior to use, thoroughly read the instructions for use

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Aug 1, 2011	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: 04260148897986
Basic UDI-DI: B-04260148897986
Reference / catalog number: RDT00016
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://paradigmspine.com/eifu/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L091199ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

RDT00012B-04260148897962On the market RFT00008B-04260148897818On the market RDI00008B-04260148898174On the market RAT209000426014889002-010WGOn the market RAT201010426014889002-004WMOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.