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

PF01.II — Class IIa MDR by QWINCE INNOVATION S.R.L.

MD Atlas
QWINCE INNOVATION S.R.L.

EUDAMED last updated this device on Dec 5, 2025

PF01.II

805689734.FARMA24RL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: QWINCE INNOVATION S.R.L.
UDI-DI code: 08056897340035
Reference / catalog number: PF01.II

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: QWINCE INNOVATION S.R.L.
SRN: IT-MF-000029688
Manufacturer status: Active

Related devices

PF01.I805689734.Farma23PZOn the market PFF01.II805689734.FARMA24RLOn the market CC01.I805689734.Farma23PZOn the market CC01.II805689734.FARMA24RLOn the market DF01.I805689734.Farma23PZOn 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

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

CW010
Consult on line user guide
CW030
.FARMA is contraindicated for patients requiring direct - medical supervision or emergency intervention
CW011
.FARMA is not intended for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention.

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 22, 2024	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: 08056897340035
Basic UDI-DI: 805689734.FARMA24RL
Reference / catalog number: PF01.II
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

Z12030682VITAL SIGNS TELEMETRY INSTRUMENTS - SOFTWARE ACCESSORIES

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

Become a partner of MD Atlas