Identity
- Trade Name
- Single-use Sterile Perforator EUDAMED
- Device Name
- Single-use Sterile Perforator EUDAMED
- Model / Reference
- LT04C.DS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955709841642 EUDAMED
- Basic UDI-DI
- 695570989983QZ EUDAMED
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Single-use Sterile Perforator by Chongqing Xishan Science & Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 695570989983QZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chongqing Xishan Science & Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009650
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 1e24376d-abc5-4a15-a203-0d1d36c46a71 61 fields · synced Jul 31, 2026