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

Aether Battery System — Class I MDR by Aether Biomedical…

MD Atlas
Aether Biomedical Spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on Jan 9, 2023

Aether Battery System

59045691522AET-BAT-BS1QE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aether Biomedical Spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05904569152222
Reference / catalog number: AET-BAT-BS1

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: Aether Biomedical Spółka z ograniczoną odpowiedzialnością
SRN: PL-MF-000005368
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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 Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: Aether Battery System
UDI-DI code: 05904569152222
Basic UDI-DI: 59045691522AET-BAT-BS1QE
Reference / catalog number: AET-BAT-BS1
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: Aether Battery System is intended to provide energy to prosthesis hand.aether battery System AET-BAT-BS1 consist of a battery pack with the necessary interconnections.
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.

Y061899UPPER EXTREMITY PROSTHESES - 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

Zeus59055153406A02T2On the market Zeus59055153406A02T2On the market Zeus59055153406A02T2On the market Zeus59055A-01-R-TAPOn the market Zeus59045A-01-L-T8UOn 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.