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luxaprint 3D mould 385 clear 500 g

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 03717

by DETAX GmbH & Co. KG

Identity

Trade Name
luxaprint 3D mould 385 clear 500 g EUDAMED
luxaprint 3D mould UV clear 500g FDA UDI
Generic Name
Earmould, custom-made FDA UDI
Device Name
3D Composite zur Herstellung von Otoplastiken EUDAMED
Model / Reference
03717 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
+EDET037171 EUDAMED
EDET037171 FDA UDI
Basic UDI-DI
++EDET0255N EUDAMED
FDA Product Code
ESD FDA UDI
EMDN Code
Q030499 OTOLOGY DEVICES - OTHER EUDAMED
GMDN Term
Earmould, custom-made FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
874.3300 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

luxaprint 3D mould 385 clear 500 g by DETAX GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union No Longer Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DETAX GmbH & Co. KG
EUDAMED SRN
DE-MF-000005995

Sources (2)

  • EUDAMED 3016e3b6-9149-4f91-8108-5b72ce4ce348 61 fields · synced Jun 18, 2026
  • FDA UDI b255e9e7-1c99-40de-9f11-64f754124a02 32 fields · synced May 24, 2026