Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021538

FEI Number

3002091543

Entity Name

CODAN MEDICAL APS.

City/State/Country

ROEDBY Sjalland, DK

Establishment Address

FAERGEVEJ 4, ROEDBY Sjalland DK 4970, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CODAN Medical ApS (Owner Number: 10046011)

Owner / Operator Contact Address

Faergevej 4, Roedby, DK-85 4970, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

safePICO PICO70 Metal frame; Plastic frame and folding Single Use Syringe & Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-04-04
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2024-04-04
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-04-04
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2014-02-11
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2014-02-11
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-02-11

Official Correspondent

Anders Sulbaek

US Agent Details

Sam Yu Business: CODAN US CORP. Email: sy@codanus.com Phone: (714) 5452111

Related Public Records

Same Entity

CODAN Medical ApS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

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1036836	Sterigenics U.S., LLC	Haw River, NC, US
3030626857	PALM MEDICAL INTERNATIONAL BV	Buggenhout Oost-Vlaanderen, BE
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021538. Last updated year: 2026. Please use registration number 8021538 when referencing this establishment in official correspondence.