Identity
- Device Name
- Surgical Needle Counter EUDAMED
- Model / Reference
- 120 x 93 x 35.2mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979973732000 EUDAMED
- Basic UDI-DI
- 697217656021002SR EUDAMED
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Category: Instrument transport trolley system
Surgical Needle Counter by Jiangsu JianYu Health Medical 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 | 697217656021002SR | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Jianyu Health Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000019315
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ebaca866-c06a-4498-b6df-66e8e1237f3d 61 fields · synced Jul 25, 2026