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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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8mm Gravity Hydrokit — 1 UDI-DI variant, MDR

MD Atlas
TRANSCENDENCIAS COMERCIALES, S.L.

Data from EUDAMED, last updated May 30, 2026

8mm Gravity Hydrokit

PP12164HKGZ1117

1 UDI-DI variant

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: TRANSCENDENCIAS COMERCIALES, S.L.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: PP12164HKGZ1117
Device name: 8mm Gravity Hydrokit
Device model: Z-11
Issuing agency: IFA
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: May 27, 2026

Manufacturer & authorised representative

Manufacturer

Name: TRANSCENDENCIAS COMERCIALES, S.L.
SRN: ES-MF-000006640
Country: Spain
Email: info@transcomsl.com
Phone: +34664492326

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KSMQEFPCQZZRXJSRM9KF4HHB

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Z-11111787628012