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InnoFine
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10509Model DE-001, DE-002, …… , DE-057, DE-058; NGB-004-D, NGB-021-D, NGB-025-D, NGB-027-D, NGB-045-D, NGB-046-D, NGB-047-D, NGB-048-D, NGB-062-D, NGB-065-D, NGB-075-D
Identity
- Trade Name
- InnoFine EUDAMEDFDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Disposable Needle Guides EUDAMEDDisposable Needle Guides for use with Hitachi-Aloka EUP-V33W, EUP-V53W, EUP-CC531, EUP-CC531s, CC41R, CC41R1 Ultrasound Transducers FDA UDI
- Model / Reference
- DE-001, DE-002, …… , DE-057, DE-058; NGB-004-D, NGB-021-D, NGB-025-D, NGB-027-D, NGB-045-D, NGB-046-D, NGB-047-D, NGB-048-D, NGB-062-D, NGB-065-D, NGB-075-D EUDAMED10509 EUDAMEDDE-009 FDA UDI
- Description
- Disposable Needle Guides for use with Hitachi-Aloka EUP-V33W, EUP-V53W, EUP-CC531, EUP-CC531s, CC41R, CC41R1 Ultrasound Transducers FDA UDI
Identifiers
- Catalog Number
- DE-009 FDA UDI
- Primary DI / UDI-DI
- 06971554725098 EUDAMEDFDA UDI
- Basic UDI-DI
- 69715547203WW EUDAMED
- FDA Product Code
- OIJ FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
InnoFine by JingFang Precision Medical Device(Shenzhen) Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69715547203WW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014096
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 6f07f938-bfdc-44c2-9ab9-e19331c5af6e 61 fields · synced Jul 24, 2026
- FDA UDI b629786e-1fe5-4a5c-994e-d1ea0add3e25 36 fields · synced May 30, 2026