Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

2797 — Class I MDR by Andromedical

MD Atlas
Andromedical

EUDAMED last updated this device on May 6, 2022

2797

84370049882797WN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Andromedical
UDI-DI code: 08437004988133
Reference / catalog number: 2797

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?

Manufacturer information

Organization name: Andromedical
SRN: ES-MF-000019363
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08437004988133
Basic UDI-DI: 84370049882797WN
Reference / catalog number: 2797
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: Penile traction device for penile shortening prevention after prostatectomy or Peyronie's disease surgery, or pre & post surgery of penile prosthesis implant.
Additional information URL: https://www.andropenis.com/ifu/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U99DEVICES FOR UROGENITAL SYSTEM - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

273284370049882732VSOn the market 292084370049882920VVOn the market 200284370049882002UEOn the market 279884370049882798WQOn the market 294784370049882947WHOn 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.