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

MC0801-XX, MC0802-XX — Class III MDD by Gelesis Srl

MD Atlas
Gelesis Srl

EUDAMED last updated this device on Feb 15, 2023

MC0801-XX, MC0802-XX

B-08055162880009

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Gelesis Srl
UDI-DI code: 08055162880009
Reference / catalog number: MC0801-XX, MC0802-XX

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: Gelesis Srl
SRN: IT-MF-000027919
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW129
Warning to possible hypersensitivity to component substances
CW275
Do not use if pregnant

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	Dec 3, 2023	May 25, 2025

Device identification

Trade name: not provided
UDI-DI code: 08055162880009
Basic UDI-DI: B-08055162880009
Reference / catalog number: MC0801-XX, MC0802-XX
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Plenity® Hydrogel is provided in porcine gelatin capsules size 00el. Plenity® is supplied in peelable blisters, each one providing the single dose of three (3) capsules, to be administered with water before lunch and dinner. The total amount of a single dose of administered hydrogel particles is 2.25 g twice per day. A monthly cardboard box contains a total number of 168 capsules in 56 pods for 28 days of therapy. Plenity® is available in two different packaging configurations, a monthly starter (welcome) kit and a monthly refill kit, both identified with a different catalog number.
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)08055162880009

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.

G030699DEVICES FOR THE NON-SURGICAL TREATMENT OF OBESITY - OTHER

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

Related devices

This device is not currently linked to any other device.

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.