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Limas Hedstrom
EUDAMEDClass IIa (EU MDR)
Ref ZHD21ASST2Model Limas Hedstrom esteriles 21mm 45-80 (6uds.)
Identity
- Trade Name
- Limas Hedstrom EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas Hedstrom esteriles 21mm 45-80 (6uds.) EUDAMEDZHD21ASST2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718051641 EUDAMED
- Basic UDI-DI
- B-06975718051641 EUDAMED
- EMDN Code
- Q030311 ENT SURGERY RASPS AND FILES, 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
Limas Hedstrom 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-06975718051641 | 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 (1)
- EUDAMED 38067392-fde2-4662-8451-4a8bbc19096e 61 fields · synced Jun 19, 2026