Eu Mdd
Eu Md Class 2a
On The Market
๐บ๐ธ United States
Waterlase Laser Tips - Sapphire
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 00647529002193
- Basic UDI-DI Code
- B-00647529002193
- Reference
- 7200740
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- BIOLASE MG LLC
Additional Description
Waterlase laser tips are accessories intended for use with the Waterlase Er,Cr:YSGG Laser Systems, such as Waterlase iPlus or Express, in a variety of soft and hard tissue procedures. Tips are attachable to the various Waterlase handpieces. The tips are offered in a variety of shapes, sizes (core diameters) and lengths to accommodate different applications and handpiece. The tips are made of quartz (glass) and sapphire. The quartz tips are for single use. The sapphire tips are reusable. The tips are offered in a non-sterile state and require sterilization by the user prior to and/or between uses, as appropriate.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12011099 | LASER SURGERY INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 4652GB410210517A | DNV MEDCERT GmbH | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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