FDA Registration
Active
🇹🇭 Thailand
EMERALD NONWOVENS INTL. CO., LTD.
Reg #: 3003495693
·
FEI: 3003495693
·
Expires 2026
Products
21
Proprietary Names
8
Establishment Types
5
Classifications
21
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Registration Details
- Registration Name
- EMERALD NONWOVENS INTL. CO., LTD.
- Registration Number
- 3003495693
- FEI Number
- 3003495693
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 88, 88/1 MOO 2, NONG CHUMPON NEAN, KAO-YOI
- City
- Phetchaburi
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K964142
Owner / Operator
- Firm Name
- EMERALD NONWOVENS INTL. CO., LTD.
- Operator Number
- 9047422
- Address
- 23/302-303 MOO 8 SOI, PHONGSIRICHAI #1 PHETKASAM RD
- City
- OPMYAI,SAMPRAN,NAKORN,PRATHON
- State
- TH-NOTA
- Postal Code
- 73160
- Country
- TH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2012-01-13 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2018-09-06 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2023-12-19 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2008-06-26 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2016-01-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2020-09-01 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2014-02-27 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2017-02-21 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2018-06-20 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2006-09-05 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2008-02-19 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-09-08 |
| Surgical Mask With Antimicrobial/Antiviral Agent | OUK | Class 2 | General, Plastic Surgery | No | 2013-05-16 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2021-04-07 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2017-02-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-06-26 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-21 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2003-11-24 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2017-06-14 |
Proprietary Names
Gemini Sterilization Wrap
BOUFFANT CAP
BEDPADS
UNDERPADS
SHEETS
Face Mask
Chemo Surgical Gown
DISPOSABLE PATIENT ISOLATION GOWN
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility