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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

ERH-35/Z/K-S L — Class I MDD by Zakład elektromechaniczn…

MD Atlas
Zakład elektromechaniczny Erhem Hończak i wspólnicy sp.j

EUDAMED last updated this device on Mar 18, 2026

ERH-35/Z/K-S L

B-05907480131468

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Zakład elektromechaniczny Erhem Hończak i wspólnicy sp.j
UDI-DI code: 05907480131468
Reference / catalog number: ERH-35/Z/K-S L

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View device family (Basic UDI)

Manufacturer information

Organization name: Zakład elektromechaniczny Erhem Hończak i wspólnicy sp.j
SRN: PL-MF-000004773
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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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: not provided
UDI-DI code: 05907480131468
Basic UDI-DI: B-05907480131468
Reference / catalog number: ERH-35/Z/K-S L
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

UDI-DI DataMatrix

Encoded

(01)05907480131468

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EMDN nomenclature code(s)

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

Y061209KNEE 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

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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.