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Disposable Injection Needles
EUDAMEDClass IIa (EU MDR)
Ref 1223Model ZRH-PN-2418-214 ZRH-PN-2418-234 ZRH-PN-2418-254 ZRH-PN-2418-216 ZRH-PN-2418-236 ZRH-PN-2418-256 ZRH-PN-2423-214 ZRH-PN-2423-234 ZRH-PN-2423-254 ZRH-PN-2423-216 ZRH-PN-2423-236 ZRH-PN-2423-256
Identity
- Trade Name
- Disposable Injection Needles EUDAMED
- Device Name
- Disposable Injection Needles EUDAMED
- Model / Reference
- ZRH-PN-2418-214 ZRH-PN-2418-234 ZRH-PN-2418-254 ZRH-PN-2418-216 ZRH-PN-2418-236 ZRH-PN-2418-256 ZRH-PN-2423-214 ZRH-PN-2423-234 ZRH-PN-2423-254 ZRH-PN-2423-216 ZRH-PN-2423-236 ZRH-PN-2423-256 EUDAMED1223 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697226348PN2VNK EUDAMED
- Basic UDI-DI
- B-697226348PN2VNK EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tissue morcellation system handpiece, line-powered
Disposable Injection Needles by Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
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- 2-piece Cleaning Adapter + 4-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class IIa
- Guide Wires — Changzhou Health Microport Medical Device Co., Ltd · Class IIa
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc. · Class II
- 3-piece valve kit — GA HEALTH COMPANY LIMITED · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-697226348PN2VNK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000027760
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a18dc543-6ff9-4482-828f-2cba0a06d646 61 fields · synced Jun 19, 2026