Micro Shaper
by Shanwei Perfect Medical Instruments Co., Ltd. 19 variants
Ref 010 006Model H Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02. K Shaper: 008 03,010 03,015 02,020 02,025 02,030 02,035 02,040 02, 010 04,010 06,015 04. F Shaper: 015 05,020 05,025 05,030 05
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69422009MicroShaper59 06942200960699 | Date8 Feb 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dental File (Micro Shaper）
- Model / Reference
- H Shaper: 008 03, 010 03, 015 02, 020 02, 025 02, 030 02, 035 02, 040 02. K Shaper: 008 03, 040 02, 010 04, 010 06, 015 04. F Shaper: 015 05, 020 05, 025 05, 030 05, 010 006
- Primary DI / UDI-DI
- 06942200960699
- Basic UDI-DI
- 69422009MicroShaper59
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanwei Perfect Medical Instruments Co., Ltd.
See all devices from Shanwei Perfect Medical Instruments Co., Ltd. →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No