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

PURESSENTIEL Respiratory Suckable… — Class IIa MDR

MD Atlas
Dr. Müller Pharma s.r.o.

EUDAMED last updated this device on Sep 4, 2024

PURESSENTIEL Respiratory Suckable Cough Tablets

85956104SLHR

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Müller Pharma s.r.o.
UDI-DI code: 08595610406844
Reference / catalog number: PC8910_005

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: Dr. Müller Pharma s.r.o.
SRN: CZ-MF-000000005
Manufacturer status: Active

Related devices

PC0203_01485956104LGGSOn the market PC8903_00285956104PSHWOn the market PC8901_00385956104PSHWOn the market ANGINAL® Oral Spray with Tea Tree Oil85956104PSHWOn the market PC8903_00185956104PSHWOn the market

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jul 17, 2024	Still on market

Device identification

Trade name: PURESSENTIEL Respiratory Suckable Cough Tablets
UDI-DI code: 08595610406844
Basic UDI-DI: 85956104SLHR
Reference / catalog number: PC8910_005
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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

Certificate health across this manufacturer's portfolio.

2023-MDR/QS-035/BSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-034/CSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-033/BSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-031refdata.certificate-status.reissued
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-032Issued
Quality management systemNotified body: 2265Expiry: Oct 20, 2028

2023-MDR/QS-031

Issued

Quality management systemNotified body: 2265Expiry: Oct 20, 2028