Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

SYPH IgM — IVDD — General IVDD by DIA.PRO DIAGNOSTIC…

MD Atlas
DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.

EUDAMED last updated this device on May 21, 2026

SYPH IgM

B-08050616040909

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
UDI-DI code: 08050616040909
Reference / catalog number: SIM.CE

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?

View device family (Basic UDI)

Manufacturer information

Organization name: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
SRN: IT-MF-000029123
Manufacturer status: Active

Related devices

Dengue virus NS1 AgB-08050616042262On the market DP5805061604INE57MOn the market HEV IgMB-08050616040183On the market SARA_Gen2805061604INCS99On the market Parvovirus B19 IgMB-08050616041036On 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.

Critical warnings

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

CW073
EUDAMED did not publish a description for this code.
CW081
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW106
EUDAMED did not publish a description for this code.
CW149
EUDAMED did not publish a description for this code.
CW158
EUDAMED did not publish a description for this code.
CW159
EUDAMED did not publish a description for this code.
CW166
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW193
EUDAMED did not publish a description for this code.
CW194
EUDAMED did not publish a description for this code.
CW422
EUDAMED did not publish a description for this code.
CW430
EUDAMED did not publish a description for this code.
CW444
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW999
P310 - Immediately call a POISON CENTER or doctor/physician.
CW306
EUDAMED did not publish a description for this code.
CW999
P363 - Wash contaminated clothing before reuse.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Apr 1, 2004	Still on market

Device identification

Trade name: SYPH IgM
UDI-DI code: 08050616040909
Basic UDI-DI: B-08050616040909
Reference / catalog number: SIM.CE
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Treponema pallidum in human serum and plasma
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08050616040909

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105010304SYPHILIS ANTIBODY IGM

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Become a partner of MD Atlas