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Non-implantable, needle guide, reusable
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref UA1251
Identity
- Trade Name
- Non-implantable, needle guide, reusable FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- Needle guide, Reusable, Class I EUDAMEDReusable Needle Guide FDA UDI
- Model / Reference
- UA1251 EUDAMEDFDA UDI
- Description
- Reusable Needle Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704916001438 EUDAMEDFDA UDI
- Basic UDI-DI
- 570491601002AF EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11049099 VARIOUS ULTRASOUND INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Needle guide, reusable
Non-implantable, needle guide, reusable by Bk Medical ApS — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, reusable.
- Redon guide needle — Spiggle & Theis Medizintechnik GmbH · Class I
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- EZU-PA5O-14 — FUJIFILM Corporation · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
- MP-2794-G16 — FUJIFILM Corporation · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bk Medical ApS
Sources (2)
- FDA UDI d0bab30b-40cb-49a7-b130-db75cd5b5609 35 fields · synced Jul 12, 2026
- EUDAMED 8ce226b2-a6c7-4b5d-816b-081a8c4614f1 61 fields · synced Jul 12, 2026