Authorized Representative
🇩🇪 Germany
Inactive
DEUTSCHE OSSTEM GmbH
SRN: DE-AR-000013953
·
Mergenthalerallee 35-37, 65760 Eschborn, Germany
Manufacturers
8
Devices
7
Certificates
5
PRRCs
0
Basic Information
- Address
- Mergenthalerallee 35-37, 65760 Eschborn, Germany
- [email protected]
- Phone
- +49 6196 777 5501
- Website
- https://www.osstem.de
- VAT Number
- DE246310063
- EORI
- DE6293840
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| OSSTEM IMPLANT CO., LTD. | 🇰🇷 South Korea | KR-MF-000020005 |
| Osstem Global | 🇰🇷 South Korea | KR-MF-000028180 |
| Toplan Co.,Ltd. | 🇰🇷 South Korea | KR-MF-000021654 |
| OSSTEM IMPLANT CO.,LTD | 🇰🇷 South Korea | KR-MF-000021655 |
| OSSTEM IMPLANT Co., Ltd. Chair Business | 🇰🇷 South Korea | KR-MF-000024564 |
| OSSTEM IMPLANT CO., LTD. | 🇰🇷 South Korea | KR-MF-000022398 |
| OSSTEM IMPLANT Co., Ltd. | 🇰🇷 South Korea | KR-MF-000020006 |
| HIOSSEN, Inc. | 🇺🇸 United States | US-MF-000020004 |
Manufacturers
OSSTEM IMPLANT Co., Ltd. Chair Business
Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·1 Importer·DNV Product Assurance AS
OSSTEM IMPLANT CO., LTD.
Manufacturer
🇰🇷 South Korea·1 Importer
OSSTEM IMPLANT CO., LTD.
Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·1 Importer·DNV Product Assurance AS
Toplan Co.,Ltd.
Manufacturer
🇰🇷 South Korea
OSSTEM IMPLANT CO.,LTD
Manufacturer
🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·DNV Product Assurance AS and DNV Product Assurance AS
HIOSSEN, Inc.
Manufacturer
🇺🇸 United States·2 Importers
OSSTEM IMPLANT Co., Ltd.
Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH
Osstem Global
Manufacturer
🇰🇷 South Korea
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 243633-2017-CE-KOR-NA-PS, C679942 | OSSTEM IMPLANT Co., Ltd. Chair Business | DNV Product Assurance AS | |
| MDD Annex II (excluding section 4) | 10804-2017-CE-KOR-NA-PS | OSSTEM IMPLANT CO., LTD. | DNV Product Assurance AS | Expired |
| MDD Annex II (excluding section 4) | 9746-2017-CE-KOR-NA-PS | OSSTEM IMPLANT CO.,LTD | DNV Product Assurance AS | Expired |
| MDD Annex II (excluding section 4) | 9746-20217-CE-KOR-NA-PS | OSSTEM IMPLANT CO.,LTD | DNV Product Assurance AS | Expired |
| MDR QMS | HZ 2292034-1 | OSSTEM IMPLANT Co., Ltd. | TÜV Rheinland LGA Products GmbH | Issued |
Devices
DENTAL TREATMENT UNITS
Device
EU MDD
·
Eu Md Class 2a
·OSSTEM IMPLANT Co., Ltd. Chair Business·On the market·2 countries
DENTAL TREATMENT UNITS
Device
EU MDD
·
Eu Md Class 2a
·OSSTEM IMPLANT Co., Ltd. Chair Business·On the market·2 countries
V-Ceph
Device
EU MDD
·
Eu Md Class 2a
·OSSTEM IMPLANT CO., LTD.·On the market·1 country
N1
Device
EU MDD
·
Eu Md Class 2b
·OSSTEM IMPLANT CO.,LTD·On the market·3 countries
T2
Device
EU MDD
·
Eu Md Class 2b
·OSSTEM IMPLANT CO.,LTD·On the market·5 countries
T2
Device
EU MDD
·
Eu Md Class 2b
·OSSTEM IMPLANT CO.,LTD·On the market·5 countries
123 Twist Drill
Device
EU MDR
·
Eu Md Class 2a
·OSSTEM IMPLANT Co., Ltd.·On the market·32 countries