Variable taper points-Wave One GOLD（Length Marked）
by Shandong Hengfeng Kerui Medical Equipment Co., Ltd 4 variants
Ref PPK LargeModel PPS 015 02, PPS 020 02, PPS 025 02, PPS 030 02, PPS 035 02, PPS 040 02, PPS 045 02, PPS 050 02, PPS 055 02, PPS 060 02, PPS 070 02, PPS 080 02, PPK 015 02, etc
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 | Number69363400APP001F5 | Date20 Nov 2025 | 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- Withdrawn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
- Absorbent Paper Points
- Model / Reference
- PPS 015 02, PPS 020 02, PPS 025 02, PPS 030 02, PPS 035 02, PPS 040 02, PPS 045 02, PPS 050 02, PPS 055 02, PPS 060 02, PPS 070 02, PPS 080 02, PPK 015 02, etc, PPK Large
- Primary DI / UDI-DI
- 06936340027046, 06936340027053
- Basic UDI-DI
- 69363400APP001F5
- EMDN Code
- Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000042567
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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