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

RB58; RB58-3P — Class I MDR by Wipak Oy

MD Atlas
Wipak Oy

EUDAMED last updated this device on Dec 11, 2021

RB58; RB58-3P

6438263ST14010NK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Wipak Oy
UDI-DI code: 06438263650207
Reference / catalog number: RB58; RB58-3P

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: Wipak Oy
SRN: FI-MF-000004496
Manufacturer status: Active

Related devices

6020-052-506438263ST14010NKOn the market 6020-051-506438263ST14010NKOn the market 6020-050-506438263ST14010NKOn the market 6020-053-506438263ST14010NKOn the market 6020-055-506438263ST14010NKOn 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

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

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06438263650207
Basic UDI-DI: 6438263ST14010NK
Reference / catalog number: RB58; RB58-3P
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: —
Additional information URL: https://www.steriking.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

S01020102STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM

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