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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

60628 — Class I MDR by Sportomed GmbH

MD Atlas
Sportomed GmbH

EUDAMED last updated this device on Sep 24, 2024

60628

PP27855KUEHLGEL252

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sportomed GmbH
UDI-DI code: 111745752504
Reference / catalog number: 60628

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Manufacturer information

Organization name: Sportomed GmbH
SRN: DE-MF-000006642
Manufacturer status: Active

Related devices

69441PP27855KUEHLGEL252On the market 69443PP27855KUEHLGEL252On the market 69447PP27855KUEHLGEL252On the market 69444PP27855KUEHLGEL252On the market 60627PP27855KUEHLGEL252On 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.

CW010
Nicht unter geschlossenen Verbänden verwenden.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 111745752504
Basic UDI-DI: PP27855KUEHLGEL252
Reference / catalog number: 60628
Issuing entity: IFA

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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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
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Software identification