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numantec
EUDAMEDClass IIa (EU MDR)
Ref 62.J9401.00.Model PP01 seriesRef 62.J9402.00
Identity
- Trade Name
- numantec EUDAMED
- Device Name
- Pre-Filled Syringe with Saline EUDAMED
- Model / Reference
- PP01 series EUDAMED62.J9401.00. EUDAMED62.J9402.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564467629 EUDAMED46971564463070 EUDAMED
- Basic UDI-DI
- 69715644600340ZU EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
numantec by Jiangsu Caina Medical 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 | 69715644600340ZU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 3c39800f-f20f-4518-83fa-45a8dbf8376e 61 fields · synced Oct 6, 2026
- EUDAMED c07aa824-ef84-4a78-bd0e-42b013466855 61 fields · synced Jul 30, 2026