Identity
- Device Name
- Working Insert EUDAMED
- Model / Reference
- N5001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014601639 EUDAMED
- Basic UDI-DI
- 69470146RJ00001510Q2 EUDAMED
- EMDN Code
- Z12020780 GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
Category: Rigid endoscope obturator
Working Insert by Hangzhou Hawk Optical Electronic Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69470146RJ00001510Q2 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7de723da-07f1-4ca2-a6fb-60518d730c57 61 fields · synced Jul 20, 2026