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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

DOCTORS KIT DKS RhD-25 — IVDD — Annex II List A IVDD

MD Atlas
Eldon Biologicals A/S

EUDAMED last updated this device on Nov 22, 2023

DOCTORS KIT DKS RhD-25

B-05713494002010

On the marketIVDD — Annex II List A

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Eldon Biologicals A/S
UDI-DI code: 05713494002010
Reference / catalog number: 660-01

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View device family (Basic UDI)

Manufacturer information

Organization name: Eldon Biologicals A/S
SRN: DK-MF-000025470
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in XI; available across 1 country total.

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

Device identification

Trade name: DOCTORS KIT DKS RhD-25
UDI-DI code: 05713494002010
Basic UDI-DI: B-05713494002010
Reference / catalog number: 660-01
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List A
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: For RhD Blood grouping.
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)05713494002010

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EMDN nomenclature code(s)

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

W0103030299RHESUS TYPING ASSAYS OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

DOCTORS KIT DKS 2511-10B-05713494002027On the market DOCTORS KIT DKS 2511-10B-05713494002034On the market DOCTORS KIT DKS 2521-10B-05713494002652On the market DOCTORS KIT DKS 2521-25B-05713494002003On the market ELDON BAG 2511-25B-05713494001839On 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.