Standard Points-02 Taper（Length Marked）
by Shandong Hengfeng Kerui Medical Equipment Co., Ltd China EUDAMED
Ref PPK 070 02Model 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 EMDN Q01010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69363400APP001F5 | Date20 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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 070 02
- Primary DI / UDI-DI
- 06936340025561, 06936340025578
- Basic UDI-DI
- 69363400APP001F5
- EMDN Code
- Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
- Device Class
- Class I
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 963f4060-c1fe-45b9-a345-7ad0c1a95577
- EUDAMED 06936340025578|69363400APP001F5