Daavlin Distributing Co.

Active in EUDAMED

Registered as The Daavlin Distributing Co. (Daavlin) in EUDAMED

Also registered as Daavlin Distributing Company

United Statesfrom EUDAMED address EUDAMED SRN US-MF-000032427

Devices: 17
Registrations: EUDAMED
FDA recalls: 116 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

European Union: EUDAMED actor
United States: FDA recalls

Catalogue17

Newest first, rows 1-17 of 17

Search and filter all 17 devices

3 Series Phototherapy Cabinet Ref K042502

Class II

Active 510(k) 510(k) II
Smart Touch Uvtherapy Multiple Machine Ref K110912

Class II

Active 510(k) 510(k) II
3 Series NeoLux Ref K230382

Class II

Active 510(k) 510(k) II
DT Controlled Phototherapy Equipment Ref K233811

Class II

Active 510(k) 510(k) II
1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 Ref K100378 Open recall

Class II

Active 510(k) 510(k) II
Dermapal With Digital Timer Ref K073587

Class II

Active 510(k) 510(k) II
ML24000 UVA-1 Phototherapy Cabinet Ref K151795

Class II

Active 510(k) 510(k) II
ML24000 Uva-1 Phototherapy Cabinet Ref K082731

Class II

Active 510(k) 510(k) II
ClearLink Controlled Phototherapy Equipment Ref K182215 Open recall

Class II

Active 510(k) 510(k) II
Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ, Uvb Narrow Band 50HZ, Uvb Narrow Band 60HZ Ref K022104

Class II

Active 510(k) 510(k) II
M Series Phototherapy Equipment Ref K210881 Open recall

Class II

Active 510(k) 510(k) II
1 Series Phototherapy Equipment Ref K220840 Open recall

Class II

Active 510(k) 510(k) II
Flex Controlled Phototherapy Equipment Ref K050695

Class II

Active 510(k) 510(k) II
Plasmaluxls Ref K100628

Class II

Active 510(k) 510(k) II
3 Series Phototherapy Unit Ref K153749

Class II

Active 510(k) 510(k) II
7 Series Phototherapy Device Ref K212510 Open recall

Class II

Active 510(k) 510(k) II
4 Series Phototherapy Unit Model 4 Series Ref K111172 Open recall

Class II

Active 510(k) 510(k) II

Rows 1-17 of 17

Company details

EUDAMED SRN: US-MF-000032427
EU VAT number: BE.0860.569.845
EUDAMED status: Active
EUDAMED registered name: The Daavlin Distributing Co.
EUDAMED abbreviated name: Daavlin
Website: www.daavlin.com
LinkedIn: linkedin.com/company/daavlin
Facebook: facebook.com/DaavlinPhototherapy
Email: [email protected]
Phone: 419-636-6304
PRRC contact: Michele Thiel(public in EUDAMED)

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 2
2023 0
2024 0
2025 1
2026 3

5 initiated before 2017

Showing the 10 most recent of 11 recalls.

2026
- 5 Mar 2026 Z-2742-2026 Class II Ongoing Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). Distribution: US Nationwide distribution. Submission number: K210881
- 5 Mar 2026 Z-2743-2026 Class II Ongoing Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). Distribution: US Nationwide distribution. Submission number: K212510
- 5 Mar 2026 Z-2744-2026 Class II Ongoing Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). Distribution: US Nationwide distribution. Submission number: K182215
2025
- 10 Dec 2025 Z-2295-2026 Class II Ongoing Some of the Calibration/Output Certificates had the outputs reversed. Distribution: US Nationwide distribution. Submission number: K220840
2022
- 26 Apr 2022 Z-1073-2022 Class II Ongoing Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.
  Submission number: K100378
- 26 Apr 2022 Z-1074-2022 Class II Ongoing Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.
  Submission number: K111172
2003
- 1 Sep 2003 Z-1233-04 Unclassified (pre-2012) Terminated Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. Distribution: Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany
- 1 Sep 2003 Z-1234-04 Unclassified (pre-2012) Terminated Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. Distribution: Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany
- 1 Sep 2003 Z-1235-04 Unclassified (pre-2012) Terminated Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. Distribution: Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany
- 1 Sep 2003 Z-1236-04 Unclassified (pre-2012) Terminated Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. Distribution: Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany

Show all 11 recalls

2003
- 1 Sep 2003 Z-1237-04 Unclassified (pre-2012) Terminated Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved. Distribution: Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany

Frequently asked questions

How many devices does Daavlin Distributing Co. have in the registry?

The registry currently lists 17 devices for Daavlin Distributing Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Daavlin Distributing Co.'s devices?

Among its 17 most recently registered devices, Daavlin Distributing Co. has devices listed in FDA 510(k) (17 devices).

What risk classes do Daavlin Distributing Co.'s devices fall under?

Among its 17 most recently registered devices, the classes recorded for Daavlin Distributing Co.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Daavlin Distributing Co.?

FDA recall records list 11 recalls initiated by Daavlin Distributing Co., the most recent initiated on 2026-03-05. 6 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Daavlin Distributing Co. in the registry?

The most recently registered devices listed for Daavlin Distributing Co. include 3 SERIES PHOTOTHERAPY CABINET, SMART TOUCH UVTHERAPY MULTIPLE MACHINE, 3 Series NeoLux and DT Controlled Phototherapy Equipment.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

Market reach

Catalogue17

3 Series Phototherapy Cabinet Ref K042502

Smart Touch Uvtherapy Multiple Machine Ref K110912

3 Series NeoLux Ref K230382

DT Controlled Phototherapy Equipment Ref K233811

1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 Ref K100378 Open recall

Dermapal With Digital Timer Ref K073587

ML24000 UVA-1 Phototherapy Cabinet Ref K151795

ML24000 Uva-1 Phototherapy Cabinet Ref K082731

ClearLink Controlled Phototherapy Equipment Ref K182215 Open recall

Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ, Uvb Narrow Band 50HZ, Uvb Narrow Band 60HZ Ref K022104

M Series Phototherapy Equipment Ref K210881 Open recall

1 Series Phototherapy Equipment Ref K220840 Open recall

Flex Controlled Phototherapy Equipment Ref K050695

Plasmaluxls Ref K100628

3 Series Phototherapy Unit Ref K153749

7 Series Phototherapy Device Ref K212510 Open recall

4 Series Phototherapy Unit Model 4 Series Ref K111172 Open recall

Company details

FDA recalls11

Recalls initiated per year

Frequently asked questions