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Sterile Dental Injection Needles for single use
EUDAMEDClass IIa (EU MDR)
Ref 27G*38mmModel 30G*11mm,30G*12mm,30G*16mm,30G*21mm,30G*25mm,27G*21mm,27G*25mm,27G*30mm,27G*32mm,27G*38mm,27G*38mm,27G*42mm
Identity
- Device Name
- Sterile Dental Injection Needles for single use EUDAMED
- Model / Reference
- 30G*11mm,30G*12mm,30G*16mm,30G*21mm,30G*25mm,27G*21mm,27G*25mm,27G*30mm,27G*32mm,27G*38mm,27G*38mm,27G*42mm EUDAMED27G*38mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976523540402 EUDAMED
- Basic UDI-DI
- 697652354YKZ001US EUDAMED
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES 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
Sterile Dental Injection Needles for single use by Shandong Caremed Medical Products Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 697652354YKZ001US | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Caremed Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000033413
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 500130d3-bfce-43ea-a114-1f88c36285c7 61 fields · synced Jun 19, 2026