OFFICIAL OPENFDA FEI RECORDFEI: 3036756245Reg Yr: 2027Malaysia (MY)

STRAITS ORTHOPAEDICS (MFG) SDN BHD

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for STRAITS ORTHOPAEDICS (MFG) SDN BHD (FEI 3036756245). Use this record to cross-check CBP ACE Affirmation of Compliance codes (`DEV` / `DFE` / `FEI`), verify the designated US Agent on file, and subscribe to automated Import Alert (DWPE) monitoring.

Registered Facility Address

PMT 10, Lorong Saga Jaya 5,, Taman Perindustrian Saga Jaya,

Perai Pulau Pinang, Malaysia (13600)

FDA FURLS Identifiers

FEI Number: 3036756245

Registration No: 3036756245 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Johannes de Waal

Totowa, NJ (USA)

973-7792400

hdewaal@medin.com

Registered FDA Product Codes, Device Classes & Commercial Names

Cross-check your commercial invoice product descriptions against these active FDA product code filings to prevent NO_510K or UNAPPROVED_NEW_DRUG port holds.

Proprietary / Commercial Brand Names on File

INTERTAN 10.5MM LAG SCREW DRILL (1000276251)Humeral Nail 8mm Broach (81016493, 71751104)UNIVERSAL META NAIL COMPRESSION DRIVER (71654528)7/16 GUIDE BOLT (71674071)INTERTAN 7MM COMPRESSION SCREW STARTER DRILL (1000276252)

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
HWC	Screw, Fixation, Bone	Class 2	21 CFR 888.3040	Requires 510(k) / Check
HSB	Rod, Fixation, Intramedullary And Accessories	Class 2	21 CFR 888.3020	Requires 510(k) / Check
JDS	Nail, Fixation, Bone	Class 2	21 CFR 888.3030	Requires 510(k) / Check
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class 2	21 CFR 888.3030	Requires 510(k) / Check

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Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for STRAITS ORTHOPAEDICS (MFG) SDN BHD (FEI 3036756245) before you wire your 70% balance payment.

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Respond-By Deadline Priority Triage

Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel

When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.

Your Full Name & Role (Required)

Include your name and title (e.g., “Sarah Chen, VP Supply Chain”).

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Work Email for 24h Legal Memo (Required)

Used strictly to deliver your conflict-free 24h FDA detention evaluation.

Please enter a valid corporate email address.

Importer Website or Amazon/Shopify Store URL (Required)

Include https:// so counsel can pre-screen product Intended Use claims.

Please enter a valid URL starting with https:// or http://.

CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3036756245) or 11-char CBP Entry # (e.g., W94-8829104-3).

Enter a 5–24 character alphanumeric FEI number or CBP Entry number.

US Port of Detention

Select the FDA District / Port holding the cargo.

Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

Determines Form 766 vs. PLAP economic viability.

Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

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Other Verified FDA FEI Establishments in Malaysia

FEI 3025603301

STRAITS ORTHOPAEDICS (MFG) SDN BHD

Simpang Ampat Pulau Pinang, Malaysia • Reg Yr 2027

FEI 3033511100

JINGXIN GROUP (M) SDN BHD

Kulai Johor, Malaysia • Reg Yr 2026

FEI 3002806591

BARD SDN. BHD.

KULIM Kedah, Malaysia • Reg Yr 2027

Frequently Asked Questions: FEI 3036756245 (STRAITS ORTHOPAEDICS (MFG) SDN BHD)

What is the FDA FEI Number for STRAITS ORTHOPAEDICS (MFG) SDN BHD?

According to public US FDA Establishment Registration records, STRAITS ORTHOPAEDICS (MFG) SDN BHD (Perai Pulau Pinang, Malaysia) is assigned FDA Facility Establishment Identifier (FEI) 3036756245 (Registration No. 3036756245) with registration year 2027.

Who is the designated US Agent for FEI 3036756245 (STRAITS ORTHOPAEDICS (MFG) SDN BHD)?

The registered US Agent on file for FEI 3036756245 is Johannes de Waal located in Totowa, NJ. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from STRAITS ORTHOPAEDICS (MFG) SDN BHD will clear US Customs without detention?

No. An active FDA FEI number or establishment registration only confirms administrative listing in FDA FURLS. Shipments can still be detained at US ports under Detention Without Physical Examination (DWPE / Import Alerts) for labeling, 510(k), cGMP, or adulteration violations.