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

N/A — Class IIb MDR by Synformulas GmbH

MD Atlas
Synformulas GmbH

EUDAMED last updated this device on May 5, 2026

N/A

PP07498KPRO16

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Synformulas GmbH
UDI-DI code: 112031272403
Reference / catalog number: N/A

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: Synformulas GmbH
SRN: DE-MF-000016381
Manufacturer status: Active

Related devices

KIJIMEA® CÔLON IRRITABLE PROPP07498KPRO16On the market N/APP07498KPRO16On the market N/APP07498KPRO16On the market N/APP07498KPRO16On the market N/APP07498KPRO16On the market

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	May 6, 2026	Still on market
Austria	May 6, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 112031272403
Basic UDI-DI: PP07498KPRO16
Reference / catalog number: N/A
Issuing entity: IFA

Classification

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

Device details

Quantity: 6
Additional product description: Kijimea® Reizdarm PRO ist ein Medizinprodukt und enthält den hitzeinaktivierten Bifido-Bakterienstamm B. bifidum HI-MIMBb75. Es wird angewendet zur Behandlung eines Reizdarmsyndroms mit den typischen Symptomen Verstopfung, Durchfall, Bauchschmerzen, Blähungen und Blähbauch.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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

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.