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Organization name
UDI-DI code
Reference / catalog number

PKA01 — Class IIb MDR by Hager & Meisinger GmbH

MD Atlas
Hager & Meisinger GmbH

EUDAMED last updated this device on May 20, 2026

PKA01

++E0HM305IIB00AA33

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hager & Meisinger GmbH
UDI-DI code: E0HMPKA011
Reference / catalog number: PKA01

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Manufacturer information

Organization name: Hager & Meisinger GmbH
SRN: DE-MF-000004966
Manufacturer status: Active

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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.

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW026
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: E0HMPKA011
Basic UDI-DI: ++E0HM305IIB00AA33
Reference / catalog number: PKA01
Issuing entity: HIBCC

Classification

Risk category: Class IIb
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://ifu.meisinger.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P01020180DENTAL IMPLANTS - ACCESSORIES

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