Synergy Health (Thailand) Limited

FDA Device Registration & Listing · Muang Chon Buri, TH · Registration 3010273867

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
3010273867
FEI Number
3010273867
Entity Name
Synergy Health (Thailand) Limited
City/State/Country
Muang Chon Buri, TH
Establishment Address
700/465 Moo 7, Muang Chon Buri TH20000, TH
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 10042227)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive Medivators2752 (CB1) - Cleanascope Liner Sets

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2020-10-06
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2012-12-20
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2013-12-30
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-01-10
FIE Needle, Fistula Gastroenterology, Urology Class 2 876.5540 2013-04-08
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 2019-02-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-01-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-18
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-11-08
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K002933 Maxxim Medical STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES 2000-10-19
K913402 Smith & Nephew Perry PERRY(R) DERMAGUARD(R) PLUS GLOVES 1991-10-02
K915174 Jms Co., Ltd. JMS APHERESIS NEEDLE 1993-03-02
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2020 AURIS HEALTH INC 2
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Similar Registrations

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3013557562 CBR ENTERPRISE LIMITED Hong Kong, HK
3015136743 STERI-TECH CO.,LTD. KAZO-SHI Saitama, JP
3014342096 KARL STORZ SE & CO KG TUTTLINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010273867. Last updated year: 2026. Please use registration number 3010273867 when referencing this establishment in official correspondence.
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