Smi Medical Instruments GmbH & Co.Kg (repackager or relabeler, NEUHAUSEN OB ECK Baden-Wurttemberg, DE): 1 new FDA device listing, incl. electrosurgical, cutting & coagulation & accessories
Smi Medical Instruments GmbH & Co.Kg (NEUHAUSEN OB ECK Baden-Wurttemberg, Delaware): 1 new FDA device listing, incl. electrosurgical, cutting & coagulation & accessories. Its amount of 1 is above the median of 2 (50th percentile). Dated 92 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 39 related DE DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Smi Medical Instruments GmbH & Co.Kg |
| Owner / operator | Smi Medical Instruments GmbH & Co Kg |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | NEUHAUSEN OB ECK Baden-Wurttemberg, DE |
| New listings | 1 |
| Devices | Electrosurgical, Cutting & Coagulation & Accessories |
| Product codes | GEI |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery |
| First new listing | 2026-08-05 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 8010871 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (40 DE records) | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-05
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (DE first): Titanlinks Logistics LLC (repackager or relabeler, Newark, D · Titanlinks Logistics LLC (repackager or relabeler, Newark, D · Karl Storz Se & Co Kg (specification developer, TUTTLINGEN B · Karl Storz Se & Co Kg (specification developer, TUTTLINGEN B · Medi.Plan GmbH & Co. Kg (foreign exporter, Dortmund North Rh · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Smi Medical Instruments GmbH & Co.Kg and 40 Delaware peers
- Delaware DeviceEstablishmentPulse records like this one: 40
- Smi Medical Instruments GmbH & Co.Kg's amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $8,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
40 / 100 Score
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Smi Medical Instruments GmbH & Co.Kg in NEUHAUSEN OB ECK Baden-Wurttemberg, Delaware?
Smi Medical Instruments GmbH & Co.Kg (NEUHAUSEN OB ECK Baden-Wurttemberg, DE), a repackager or relabeler, added 1 FDA device listing on 2026-08-05.
How does Smi Medical Instruments GmbH & Co.Kg compare to other Delaware DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 92 days old; check the official source for later updates before acting.
Smi Medical Instruments GmbH & Co.Kg vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Smi Medical Instruments GmbH & Co.Kg | NEUHAUSEN OB ECK Baden-Wurttemberg, DE | 1 | 50th | 2026-08-05 |
| Titanlinks Logistics LLC | Newark, DE | 336 | 99th | 2026-10-06 |
| Titanlinks Logistics LLC | Newark, DE | 340 | 99th | 2026-10-22 |
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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.