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FDA Import Refusal 1FX-2189364-8/60002/1 — OrbusNeich Medical (Shenzhen) Co., Ltd.

OrbusNeich Medical (Shenzhen) Co., Ltd. — FEI 3003775186

The FDA refused shipment 1FX-2189364-8/60002/1 from OrbusNeich Medical (Shenzhen) Co., Ltd. (China) on April 7, 2026. The refused product falls under Devices — CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL. Cited charges: 118,341,3904,3905,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date: April 7, 2026
Country: China
Product Category: Devices
Product Code: 74LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Charges: 118,341,3904,3905,508

Other import refusals

1FX-3747031-6/10002/1 (Wed May 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
1FX-3747031-6/40002/1 (Wed May 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
1FX-3747248-6/10002/1 (Wed May 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
1FX-3747031-6/30002/1 (Wed May 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
1FX-2189364-8/10002/1 (Tue Apr 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA Import Refusal 1FX-2189364-8/60002/1 — OrbusNeich Medical (Shenzhen) Co., Ltd.

Refusal Details

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Other import refusals

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