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NanoShaper
EUDAMEDClass IIa (EU MDR)
Ref ZNS21Z0007Model NanoShaper 21mm ZN7 (6 units)Ref ZNS21ASST3Model NanoShaper 21mm ZN1-ZN6 (6 units)Ref ZNS21ASST2Model NanoShaper 21mm ZN1-ZN3 (6 units)Ref ZNS21Z0004Model NanoShaper 21mm ZN4 (6 units)Ref ZNS21Z0005Model NanoShaper 21mm ZN5 (6 units)Ref ZNS21Z0006Model NanoShaper 21mm ZN6 (6 units)Ref ZNS25ASST3Model NanoShaper 25mm ZN1-ZN6 (6 units)Ref ZNS31ASST3Model NanoShaper 31mm ZN1-ZN6 (6 units)
Identity
- Trade Name
- NanoShaper EUDAMED
- Model / Reference
- NanoShaper 21mm ZN7 (6 units) EUDAMEDZNS21Z0007 EUDAMEDNanoShaper 21mm ZN1-ZN6 (6 units) EUDAMEDZNS21ASST3 EUDAMEDNanoShaper 21mm ZN1-ZN3 (6 units) EUDAMEDZNS21ASST2 EUDAMEDNanoShaper 21mm ZN4 (6 units) EUDAMEDZNS21Z0004 EUDAMEDNanoShaper 21mm ZN5 (6 units) EUDAMEDZNS21Z0005 EUDAMEDNanoShaper 21mm ZN6 (6 units) EUDAMEDZNS21Z0006 EUDAMEDNanoShaper 25mm ZN1-ZN6 (6 units) EUDAMEDZNS25ASST3 EUDAMEDNanoShaper 31mm ZN1-ZN6 (6 units) EUDAMEDZNS31ASST3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512507582 EUDAMED06942512507544 EUDAMED06942512502525 EUDAMED06942512507551 EUDAMED06942512507568 EUDAMED06942512507575 EUDAMED06942512507599 EUDAMED06942512507643 EUDAMED
- Basic UDI-DI
- B-06942512507582 EUDAMEDB-06942512507544 EUDAMEDB-06942512502525 EUDAMEDB-06942512507551 EUDAMEDB-06942512507568 EUDAMEDB-06942512507575 EUDAMEDB-06942512507599 EUDAMEDB-06942512507643 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NanoShaper by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942512507582 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (8)
- EUDAMED 89258f10-02cc-486e-a56c-14f5c2278997 61 fields · synced Aug 4, 2026
- EUDAMED 71cefa39-4d09-4ca4-ae56-de416cab1803 61 fields · synced May 17, 2026
- EUDAMED fadbb492-f4b6-44f7-9b39-4756466b2c8a 61 fields · synced May 17, 2026
- EUDAMED d0aa2b94-0246-43b4-9fae-15f8031524e0 61 fields · synced May 17, 2026
- EUDAMED 25b8f19d-4c84-4e1c-8ce2-7a0398bd0150 61 fields · synced May 18, 2026
- EUDAMED 4f8f73a4-a876-4f44-85f9-95670bb41ec5 61 fields · synced May 18, 2026
- EUDAMED 0572da42-2716-4d74-94b0-89be8f04d452 61 fields · synced May 19, 2026
- EUDAMED 85bbcc37-8258-4b2b-a7ab-8d31c5893d51 61 fields · synced May 19, 2026