1. Authorisation Number

:

DE_BW_03_WDA_2023_0009

2. Name of Authorisation Holder

:

DENTEQ Medical Technologies e.K.

(ORG-100049645 / LOC-100086293)

3. Address(es) of Site(s)

:

Hafenstrasse 12, Leopoldshafen, Eggenstein-Leopoldshafen, Baden-Wuerttemberg, 76344, GERMANY 

4. Legally registered address of Authorisation Holder

:

Hafenstrasse 12, Leopoldshafen, Eggenstein-Leopoldshafen, Baden-Wuerttemberg, 76344

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

:

Confidential, Confidential

8. Signature

:

9. Date

:

2023-11-16

10. Annexes attached

:

Annex 1 Scope of wholesale distribution authorisation

Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number

Annex 3 (Optional) Name(s) of responsible person(s)

Annex 4 (Optional) Date of Inspection on which authorisation was granted

Annex 5 (Optional) Additional provisions based on national requirements

Name and address of the site: DENTEQ Medical Technologies e.K.

(ORG-100049645 / LOC-100086293)

, Hafenstrasse 12, Leopoldshafen, Eggenstein-Leopoldshafen, Baden-Wuerttemberg, 76344, GERMANY   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  to 1.1 Only skin and hand disinfectants as well as finished medicinal products used exclusively in dentistry (Section 47 Paragraph 1 No. 7 Medicines Act)

zu 1.1: Nur Haut- und Händedesinfektionsmittel sowie Fertigarzneimittel ausschließlich in der Zahnheilkunde verwendet (§ 47 Abs. 1 Nr. 7 Arzneimittelgesetz)

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation

DE_BW_03_WDA_2023_0009

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