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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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Organization name
UDI-DI code
Reference / catalog number

R48; R48-3P — Class I MDR by Wipak Oy

MD Atlas
Wipak Oy

EUDAMED last updated this device on Dec 11, 2021

R48; R48-3P

6438263ST14010NK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Wipak Oy
UDI-DI code: 06438263640727
Reference / catalog number: R48; R48-3P

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Manufacturer information

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

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: 06438263640727
Basic UDI-DI: 6438263ST14010NK
Reference / catalog number: R48; R48-3P
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)

S01020101FLAT STERILISATION REELS, 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

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.