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EUDAMED last updated this device on Aug 2, 2026
697599466ZW3028Swept-source Optical Biometer is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by TowardPi (Shanghai) Medical Technology Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06975994660230ZW-30 TPCN-MF-000033952(01)06975994660230
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
4 warnings recorded — scroll inside the panel to see all entries.
It is forbidden to disassemble the product without the consent of the company, otherwise it may cause the danger of electric shock or laser radiation.
This product complies with the requirements of IEC 60825-1:2014 and EN IEC 6025-1:2014+A11:2021, and belongs to Class 1 laser equipment. When repairing a device, the maintenance personnel may be exposed to laser radiation exceeding Class 1 laser radiation. Thus, the maintenance personnel shall receive strict training from our company before they can repair the equipment. During maintenance, they shall wear laser protective glasses.
OTHER
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 placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Jul 20, 2026 | Jul 19, 2029 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120102COMPUTERISED OPTICAL BIOMETERSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
MDR 790576AmendedNotified 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.
View in glossary →