EU → North America Device Access

Deltamedica GmbH

DE-MF-000006440 · Germany · Reutlingen

Deltamedica GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa10

Most frequent device types declared: 250 ml Plastic bottle, 3000 ml, 3000mL, 500 ml Glass bottle, 5000 mL.

Among these devices, 11 are declared sterile.

Devices declared under this manufacturer

Catalogue references include 00893825, 02861663, 03567718, 04026433, 04026456, 0893848.

European nomenclature codes declared: A03040299, Q02030203, W0103020999.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryDELTAMED GMBH (DE) · FDA 3002789526
Devices in EUDAMED11
Country of registrationGermany

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryDELTAMED GMBH

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record13
Currently active0
Class 2 devices4
Class 3 devices9
First licensed2004-07-14

Licence types: Device Family (6), System (3), Device Group Family (2), Single Device (2).

Licensed under: RENAMEL RESIN COMPOSITE RESTORATIVE, INSURE RESIN DENTAL CEMENT, COSMECORE, COSMESEAL, RENAMEL NANO +PLUS LIGHT-CURED DENTAL COMPOSIT, P PRO CROWN & BRIDGE.

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