Avalanche Med Sdn Bhd

FDA Device Registration & Listing · Simpang Ampat Pulau Pinang, MY · Registration 3012587552

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012587552
FEI Number
3012587552
Entity Name
Avalanche Med Sdn Bhd
City/State/Country
Simpang Ampat Pulau Pinang, MY
Establishment Address
NO.1 & 3, LORONG INDUSTRI SERI JURU 1, Taman Industri Seri Juru, Simpang Ampat Pulau Pinang 14100, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Avalanche Med Sdn Bhd (Owner Number: 10052252)
Owner / Operator Contact Address
No.1 & 3, Lorong Industri Seri Juru 1,, Taman Industri Seri Juru, Simpang Ampat,, Penang, MY-NOTA 14100, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-04-09
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-08-28
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2021-01-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2018-04-09
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-04-09
EIG Retractor, All Types Dental Class 1 872.4565 2017-09-08
HXD Clamp General, Plastic Surgery Class 1 878.4800 2018-04-09
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2018-04-09
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-07-06

Official Correspondent

Dietmar Kapp

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Avalanche Med Sdn Bhd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-05 N/A 1
Hem-o-lok Endo5 Ligation Applier
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number Establishment Name Location
8040884 HILBRO (PVT) LTD. SIALKOT Punjab, PK
9611283 DIMEDA INSTRUMENTE GMBH TUTTLINGEN Baden-Wurttemberg, DE
1421101 Instrumed International Inc dba Avalign German Specialty Instruments SCHAUMBURG, IL, US
3008808049 SURGICRAFTS Sialkot Punjab, PK
3003807268 HIVE INTERNATIONAL PVT LTD. Sialkot Punjab, PK
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012587552. Last updated year: 2026. Please use registration number 3012587552 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.