# Medi.Plan GmbH & Co. Kg (foreign exporter, Dortmund North Rhine-Westphalia, DE): 14 new FDA device listings, incl. gown, surgical

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Medi.Plan GmbH & Co. Kg |
| Owner / operator | MEDI.PLAN GmbH & Co. KG |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Dortmund North Rhine-Westphalia, DE |
| New listings | 14 |
| Devices | Gown, Surgical; Hood, Surgical; Electrosurgical, Cutting & Coagulation & Accessories; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Instrument, Ultrasonic Surgical; Device, Intravascular Catheter Securement; Blade, Saw, General & Plastic Surgery, Surgical; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Orthopedic Stereotaxic Instrument; Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Product codes | FYA, FXY, GEI, HWE, LFL, KMK, GFA, ERL, OLO, HBE |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | General, Plastic Surgery, General Hospital, Ear, Nose, Throat, Neurology |
| Brand names | T7PLUS TOGA ZIPPER WITH PEELAWAY FACE SHIELD PACK 9; T7PLUS SURGICAL HOOD WITH PEELAWAY FACE SHIELD PACK 28; T7 SURGICAL HOOD WITH PEELAWAY FACE SHIELD PACK 28; COLORADO MICRODISSECTION NEEDLE 3CM STRAIGHT, 3/32 IN. SLEEVE DIAM. PACK 1; FLYTE HOOD PEELAWAY STERI-SHIELD PACK 32; Hood Surgical article(s); Prep Plus - Cartridge (powered bone mill cartridge); SONOPET IQ IRRIGATION SUCTION CASSETTE PACK 4 |
| First new listing | 2026-07-06 |
| Latest new listing | 2026-08-31 |
| FDA registration number | 3033536319 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.