Additera Co.,Ltd. (contract manufacturer, Jungwon-gu, Seongnam-si Gyeonggi, KR): 1 new FDA device listing, incl. plate, cranioplasty, preformed, non-alterable
Additera Co.,Ltd. (Jungwon-gu, Seongnam-si Gyeonggi): 1 new FDA device listing, incl. plate, cranioplasty, preformed, non-alterable. Its amount of 1 is above the median of 2 (50th percentile). Dated 155 days ago, it serves as a historical benchmark. Score 55/100. 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 15 published fields of this record are shown below. Locked: 121 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Additera Co.,Ltd. |
| Owner / operator | AddiTera Co.,Ltd. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Jungwon-gu, Seongnam-si Gyeonggi, KR |
| New listings | 1 |
| Devices | Plate, Cranioplasty, Preformed, Non-Alterable |
| Product codes | GXN |
| Device classes | Class II |
| Medical specialties | Neurology |
| Brand names | EASYMADE TI |
| First new listing | 2026-06-03 |
| Latest new listing | 2026-06-03 |
| FDA registration number | 3045823936 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (122 KR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-06-03
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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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: Additera Co.,Ltd. and 122 KR peers
- KR DeviceEstablishmentPulse records like this one: 122
- Additera Co.,Ltd.'s amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $24,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Additera Co.,Ltd. in Jungwon-gu, Seongnam-si Gyeonggi?
Additera Co.,Ltd. (Jungwon-gu, Seongnam-si Gyeonggi, KR), a contract manufacturer, added 1 FDA device listing on 2026-06-03.
How does Additera Co.,Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 155 days old; check the official source for later updates before acting.
Additera Co.,Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Additera Co.,Ltd. | Jungwon-gu, Seongnam-si Gyeonggi, KR | 1 | 50th | 2026-06-03 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
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- Millstone Medical Outsourcing LLC.
- Karl Storz Endoscopy-America, Inc.
- Orchid Orthopedic Solutions Oregon, Inc.
- Philips Ultrasound LLC
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DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: Foreign establishment
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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.