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

4000 — Class IIa MDD by Schaefers Medizintechnik…

MD Atlas
Schaefers Medizintechnik GmbH

EUDAMED last updated this device on Jan 28, 2023

4000

B-110939660846

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Schaefers Medizintechnik GmbH
UDI-DI code: 110939660846
Reference / catalog number: 4000

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: Schaefers Medizintechnik GmbH
SRN: DE-MF-000006991
Manufacturer status: Active

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 1985	Still on market

Device identification

Trade name: not provided
UDI-DI code: 110939660846
Basic UDI-DI: B-110939660846
Reference / catalog number: 4000
Issuing entity: IFA

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: http://www.schaefers-medizintechnik.de/downloads/gebrauchsanweisung_irrimed_classic_4000_de.pdf
Additional information URL: http://www.schaefers-medizintechnik.de/downloads/gebrauchsanweisung_irrimed_classic_4000_de.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A03010299IRRIGATION CONTROLLERS - 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

25070KB-111751032047On the market 5000B-110953688359On the market 455000B-111825111611On the market 454000B-111825114530On the market 5006PP28376MDN1202.I44On 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.