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

SpaceFlex Shoulder Instrument Kit — Class I MDR by G21 S.R.L.

MD Atlas
G21 S.R.L.

EUDAMED last updated this device on Mar 12, 2025

SpaceFlex Shoulder Instrument Kit

0805896472spaceflexHE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: G21 S.R.L.
UDI-DI code: 08058964727251
Reference / catalog number: G210.00.022

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: G21 S.R.L.
SRN: IT-MF-000030085
Manufacturer status: Active

Related devices

80TBD039B-08058964726698On the market Biopsy KitB-08058964725455On the market Biopsy KitB-08058964726018On the market Biopsy KitB-08058964726650On the market Disp. Mixing Bowl-OB-08058964723758On 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

No critical warnings reported for this device.

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		Still on market

Device identification

Trade name: SpaceFlex Shoulder Instrument Kit
UDI-DI code: 08058964727251
Basic UDI-DI: 0805896472spaceflexHE
Reference / catalog number: G210.00.022
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: SpaceFlex Shoulder Instrument Kit is intended to be used in conjunction with the SpaceFlex Shoulder medical device to allow proper fitting of the spacer molds. It is reusable not sterile set of tools, that need to be sterilised bedore use.
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.

P099002ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS

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