Authorized Representative
π©πͺ Germany
Active
AeMi World e.K
SRN: DE-AR-000007704
Β·
Bugenhagenstr. 8, 10551 Berlin, Germany
Manufacturers
14
Devices
76
Certificates
2
PRRCs
1
Basic Information
- Address
- Bugenhagenstr. 8, 10551 Berlin, Germany
- [email protected]
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| ILLUCO Corporation Ltd. | π°π· South Korea | KR-MF-000012082 |
| MEDIMECCA | π°π· South Korea | KR-MF-000021831 |
| OHDAE Corporation | π°π· South Korea | KR-MF-000025003 |
| VASSEN | π°π· South Korea | KR-MF-000027045 |
| OHDAE Corporation | π°π· South Korea | KR-MF-000025038 |
| Incuram | π°π· South Korea | KR-MF-000025630 |
| Truabutment Inc. | π°π· South Korea | KR-MF-000030156 |
| Across Co., Ltd. | π°π· South Korea | KR-MF-000012936 |
| Goodpl Inc. | π°π· South Korea | KR-MF-000032603 |
| J&S CO., Ltd | π°π· South Korea | KR-MF-000036025 |
| SIMFLE STICK Co., Ltd. | π°π· South Korea | KR-MF-000037179 |
| Ubiosis | π°π· South Korea | KR-MF-000028123 |
| TruAbutment Inc. | πΊπΈ United States | US-MF-000043448 |
| SG Healthcare Co.,Ltd | π°π· South Korea | KR-MF-000011322 |
Manufacturers
OHDAE Corporation
Manufacturer
π°π· South Korea·9 Basic UDI-DIs·9 Devices
OHDAE Corporation
Manufacturer
π°π· South Korea
ILLUCO Corporation Ltd.
Manufacturer
π°π· South Korea·1 Basic UDI-DI·1 Device·3 Importers
VASSEN
Manufacturer
π°π· South Korea
SG Healthcare Co.,Ltd
Manufacturer
π°π· South Korea
Goodpl Inc.
Manufacturer
π°π· South Korea
J&S CO., Ltd
Manufacturer
π°π· South Korea
MEDIMECCA
Manufacturer
π°π· South Korea
Incuram
Manufacturer
π°π· South Korea·15 Basic UDI-DIs·15 Devices·1 Importer·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ε.
SIMFLE STICK Co., Ltd.
Manufacturer
π°π· South Korea·1 Basic UDI-DI·4 Devices
TruAbutment Inc.
Manufacturer
πΊπΈ United States·1 Basic UDI-DI·46 Devices
Across Co., Ltd.
Manufacturer
π°π· South Korea·1 Importer
Truabutment Inc.
Manufacturer
π°π· South Korea
Ubiosis
Manufacturer
π°π· South Korea·1 Basic UDI-DI·1 Device·1 Importer·3EC International a.s.
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex V | M.2020.106.13483 | Incuram | UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ε. | Expired |
| MDD Annex II (excluding section 4) | 2019-MDD/QS-020/A | Ubiosis | 3EC International a.s. | Expired |
Devices
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE
Device
EU MDD
·
Eu Md Class 1
·OHDAE Corporation·On the market
ILLUCO
Device
EU MDR
·
Eu Md Class 1
·ILLUCO Corporation Ltd.·On the market
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·Incuram·On the market·2 countries
GD TONE-UP Professional V
Device
EU MDR
·
Eu Md Class 1
·SIMFLE STICK Co., Ltd.·On the market
2nd Derma Gold PTT
Device
EU MDR
·
Eu Md Class 1
·SIMFLE STICK Co., Ltd.·Not intended for eu market
Simfle-Stick PLLA30
Device
EU MDR
·
Eu Md Class 1
·SIMFLE STICK Co., Ltd.·Not intended for eu market
GD TONE-UP Professional
Device
EU MDR
·
Eu Md Class 1
·SIMFLE STICK Co., Ltd.·Not intended for eu market
TruDriver Handle
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
TruDriver Handle
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
TruDriver Handle
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap Small
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap Small
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap Small
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap Small
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap Small
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap Small
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
HS Cap
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Screw
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Screw
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Screw
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Screw
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Screw
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Screw
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Kit
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Kit
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Kit
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Kit
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Kit
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Kit
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
ioConnect Kit
Device
EU MDR
·
Eu Md Class 1
·TruAbutment Inc.·On the market
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
·
Eu Md Class 3
·Ubiosis·On the market·4 countries