Data / Medical devices / United States / Scribe Opco, LLC
Scribe Opco, LLC: FDA-registered device maker in Red Wing, MN, United States, 1 510(k) clearance
Scribe Opco, LLC is registered with the FDA (registration 2111760) in Red Wing, MN, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2111760
- Address
- 5151 Moundview Dr, Red Wing, MN, United States, 55066
- Owner or operator
- SCRIBE OPCO, INC., dba Koozie Group (9010937)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 16, 1998
- Registered through
- 2026
- Brand names listed
- 20417 Retro First Aid Tin, 3 PLY DISPOSABLE MASK, 40011 Pocket First Aid Kit, 40039 Translucent Personal First Aid Kit, 40040 First Aid Pouch, 40044 Compact First Aid Kit, 40045 Deluxe First Aid Kit, 40047 Personal First Aid Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Repackager or relabeler | accessdata.fda.gov |
| Protector, Hearing (Insert) | EWD | U | Repackager or relabeler | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2010 | K101387 | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | FLL | Substantially Equivalent | Fudakang Industries Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Protector, Hearing (Insert)
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Continuous Measurement Thermometer
- All makers of Accessory, Surgical Apparel
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
Updated August 3, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.