- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED data as of Jul 21, 2026
EUDAMED last updated this device on Jul 1, 2026
50560910OrthoInstKFSternberg Lip Retractors Style B 160mm is an EU MDR-regulated medical device on the European market. It is classified as Class I. Manufactured by DB Orthodontics Limited. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the official record on MD Atlas.
05060429407106DB04-0197(01)05060429407106
European Medical Device Nomenclature — the EU product classification assigned to this device.
L150799ORTHODONTIC INSTRUMENTS, REUSABLE - OTHERGB-MF-000023271The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
No certificate specifically references this device's Basic UDI-DI.
50560910OrthoInstKFOn the marketSternberg Lip Retractors Style B 140mm50560910OrthoInstKFOn the marketSternberg Lip Retractors Style B 140mm50560910OrthoInstKFOn the marketSternberg Lip Retractors Style B 160mm50560910OrthoInstKFOn the marketSternberg Lip Retractors Style B 180mm50560910OrthoInstKFOn the marketSternberg Lip Retractors Style B 180mm50560910OrthoInstKFOn the marketCertificate health across this manufacturer's portfolio.
MDR 835077SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.