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

C11 L — Class I MDR by PRIM, S.A.

MD Atlas
PRIM, S.A.

EUDAMED last updated this device on Dec 4, 2022

C11 L

843404825ORTESISTIBIAXY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PRIM, S.A.
UDI-DI code: 08426680668552
Reference / catalog number: C11 L

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: PRIM, S.A.
SRN: ES-MF-000004651
Manufacturer status: Active

Related devices

AQTIVO Skin Elastic knee brace L843404825ORTESISRODILLASDOn the market AQTIVO Skin Elastic knee brace XL843404825ORTESISRODILLASDOn the market Closure for Milwaukee corset843404825CORSECXOn the market COREX+ Bivalve Corset843404825CORSECXOn the market Pavlik Harness (OP)843404825ORTESISCADERAYTOn 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.

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: 08426680668552
Basic UDI-DI: 843404825ORTESISTIBIAXY
Reference / catalog number: C11 L
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: Ortesis infantil de corrección del miembro inferior.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y061218HIP-KNEE-ANKLE-FOOT ORTHOSES

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