EU Manufacturer
๐จ๐ณ China
Active
Leo Medical Co., Ltd.
SRN: CN-MF-000012017
ยท
No. 10 Building, 23 Middle Huashan Road 23, 213022 Changzhou City, Jiangsu Province, China
Basic UDI-DIs
14
Total Devices
20
On Market
20
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
4
Basic Information
- Address
- No. 10 Building, 23 Middle Huashan Road 23, 213022 Changzhou City, Jiangsu Province, China
- [email protected]
- Phone
- 86-0519-85150750
Regulatory Overview
Regulation
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Eu Mdr
12
Eu Mdd
2
Classification
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Eu Md Class 2a
10
Eu Md Class 2b
4
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | NO. G10864670010 Rev.02 | TรV SรD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 4 countries across Europe.
๐ฌ๐ท Greece
๐ซ๐ท France
๐ฎ๐น Italy
๐ต๐ฑ Poland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| BILIARY TUBES | EU MDR | Eu Md Class 2a | On Market | 0 |
| BILIARY TUBES | EU MDR | Eu Md Class 2a | On Market | 0 |
| DIGESTIVE ENDOSCOPY DEVICES - OTHER | EU MDR | Eu Md Class 2a | On Market | 0 |
| DIGESTIVE ENDOSCOPY DEVICES - OTHER | EU MDD | Eu Md Class 2a | On Market | 1 |
| DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES | EU MDR | Eu Md Class 2a | On Market | 0 |
| DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, NON-REVOLVING | EU MDR | Eu Md Class 2a | On Market | 0 |
| DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, NON-REVOLVING | EU MDR | Eu Md Class 2a | On Market | 0 |
| DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES | EU MDR | Eu Md Class 2a | On Market | 0 |
| GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER | EU MDR | Eu Md Class 2a | On Market | 0 |
| PAPILLOTOMES / SPHINCTEROTOMES - OTHER | EU MDR | Eu Md Class 2b | On Market | 0 |
| PAPILLOTOMES / SPHINCTEROTOMES - OTHER | EU MDD | Eu Md Class 2b | On Market | 1 |
| POLYPECTOMY DEVICES - OTHER | EU MDR | Eu Md Class 2a | On Market | 0 |
| POLYPECTOMY SNARES - OTHER | EU MDR | Eu Md Class 2b | On Market | 0 |
| POLYPECTOMY SNARES, NON-REVOLVING | EU MDR | Eu Md Class 2b | On Market | 0 |
| POLYPECTOMY SNARES, REVOLVING | EU MDR | Eu Md Class 2b | On Market | 0 |
| POLYPECTOMY SNARES, REVOLVING | EU MDR | Eu Md Class 2b | On Market | 0 |
| POLYPECTOMY SNARES, REVOLVING | EU MDR | Eu Md Class 2b | On Market | 0 |
| POLYPECTOMY SNARES, REVOLVING | EU MDR | Eu Md Class 2b | On Market | 0 |
| POLYPECTOMY SNARES, REVOLVING | EU MDR | Eu Md Class 2b | On Market | 0 |
| POLYPECTOMY SNARES, REVOLVING | EU MDR | Eu Md Class 2b | On Market | 0 |