Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

100025543 — Class I MDR by spektramed GmbH

MD Atlas
spektramed GmbH

EUDAMED last updated this device on Oct 20, 2022

100025543

425055662315043C9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: spektramed GmbH
UDI-DI code: 04250556606300
Reference / catalog number: 100025543

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: spektramed GmbH
SRN: DE-MF-000005711
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW030
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04250556606300
Basic UDI-DI: 425055662315043C9
Reference / catalog number: 100025543
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.spektramed.de/produkte/rumpf/ergospine-pro-thorako-lumbalorthese-ohne-mobilisierungsfunktion-mit-smart-adapter
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060309THORACOLUMBOSACRAL SPINE ORTHOSES

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

100014072425055662315044CBOn the market 100014071425055662315044CBOn the market 100014073425055662315044CBOn the market 100014070425055662315044CBOn the market 100023002/1425055662315040C3On 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.