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ImaJin

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
ImaJin FDA UDI
Generic Name
Urological surgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
BCHS82 FDA UDI

Identifiers

Catalog Number
BCHS82 FDA UDI
Primary DI / UDI-DI
05701780340649 FDA UDI
FDA Product Code
FAD FDA UDI
GMDN Term
Urological surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 8 French FDA UDI
Length — 20 Centimeter FDA UDI

Category: Urological surgical procedure kit, non-medicated, single-use

ImaJin by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urological surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 0bd0d1fe-0a06-46a7-a1f1-24e0799f9aa0 36 fields · synced Jun 1, 2026