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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

Mallet HEATH, 255 mm, — Class I MDD by Fabryka Narzędzi…

MD Atlas
Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa

EUDAMED last updated this device on Mar 9, 2026

Mallet HEATH, 255 mm,

B-05904151405729

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa
UDI-DI code: 05904151405729
Reference / catalog number: CK 42

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Manufacturer information

Organization name: Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa
SRN: PL-MF-000052302
Manufacturer status: Active

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Critical warnings

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

CW129
Products made of stainless steel contain metals (in the form of alloying additives or in trace amounts) that may cause allergies (Nickel, Chromium, Cobalt). The product is contraindicated for people with allergies to any component of steel.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: Mallet HEATH, 255 mm,
UDI-DI code: 05904151405729
Basic UDI-DI: B-05904151405729
Reference / catalog number: CK 42
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

L0903ORTHOPAEDIC SURGERY HAMMERS, REUSABLE

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

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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.