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

ClinMass® — IVDD — General IVDD by RECIPE Chemicals +…

MD Atlas
RECIPE Chemicals + Instruments GmbH

EUDAMED last updated this device on Apr 26, 2024

ClinMass®

B-MS5100B4

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: RECIPE Chemicals + Instruments GmbH
UDI-DI code: D-MS5100B4
Reference / catalog number: MS5100

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: RECIPE Chemicals + Instruments GmbH
SRN: DE-MF-000032553
Manufacturer status: Active

Related devices

ClinRep® Precolumns for CDT in Serum4049195CDTCLMNTMOn the market ClinCal® Serum Calibrator Set lyophilised, for CDT4049195CDTCTRLV8On the market ClinCal® Plasma Calibrator, lyophil., for Amino Acids (by Amino Acid Analyzer (AAA))B-10213ECOn the market ClinCal® Serum Calibrator Set, lyophil., for Amiodarone and Desethylamiodarone (Level 0 - 3)B-9909CVOn the market ClinCal® Serum Calibrator, lyophil., for Vitamins B64049195VITBCAL4YOn 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

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

CW018
See IFU sections 2.1.1 - 2.1.3

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: ClinMass®
UDI-DI code: D-MS5100B4
Basic UDI-DI: B-MS5100B4
Reference / catalog number: MS5100
Issuing entity: EUDAMED

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: This ClinMass® Complete Kit is intended for the quantitative determination of methylmalonic acid from human serum, plasma and urine by HPLC coupled with tandem mass spectrometry (LC-MS/MS). The kit is intended for use by professional users in clinical and medical laboratories only. The kit components have to be used in accordance with corresponding user manual. The kit is not designed for combination with components from other manufacturers.
Additional information URL: https://recipe.de/de/myrecipe
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102070299VITAMIN TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification