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Pharmaplast SAE

Egypt · Alexandria · www.pharmaplast-online.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN EG-MF-000004501

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 190Class IIa 87Class IIb 23

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

24listed device types

Class I 22Class II 0Class III 0unclassified 2

plus 25 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

68registered device records

Class I 41Class IIa 14Class IIb 10System or Procedure Pack 3

BRBrazilANVISA

130registered devices

Class I 109Class II 21

172 including historic records

SASaudi ArabiaSFDA

29registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

59valid device licences

Class I 58Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 5IIa 2IIb 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union4,374 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States25 registration records, 1 510(k), 0 PMA

United Kingdom68 confirmed, 0 excluded

Brazil130 confirmed, 3 excluded

Saudi Arabia29 confirmed, 0 excluded

Manufacturer names merged into this page: PHARMAPLAST S.A.E. · PHARMAPLAST S.A.E · pharmaplast S.A.E · Pharmaplast SAE

Regulatory identity

EU manufacturer SRN: EG-MF-000004501
EU authorised representative: E C REP LIMITED
UK responsible person: Responsible Person Ltd

FDA 510(k) clearances by year

12013 · K130553

FDA listed device types

showing 8 of 24

Bag, Urine Collecting, Ureterostomy 1Appliance, Colostomy, Disposable 1First Aid Kit Without Drug 1Adhesive Backed Thermal Skin Patches 1Strip, Adhesive, Closure, Skin 1Dressing, Wound, Occlusive 1Bag, Urinary, Ileostomy 1Nursing Pad, Hydrogel 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05056585804613	Dr.Scholl's Bunion Cushions	Class I
EU	05045099820486	Boots Faster Healing Silicone-Foam Dressing	Class IIb
EU	05045099820417	Boots Faster Healing Hydrogel Dressing	Class IIb
EU	06221329036523	Cure-Aid® Nose Plaster	Class I
UK	34864	Pharmapore PU Frame Style	Class I
UK	58108	Cavidagel and Cavidagel Burn Dressing	Class IIa
UK	33056	Pharma POP	Class I
US	K130553	ABSOCLEAR	2013-07-03
BR	80327919002	Pharmapore Post Operative	Class II
BR	10150470725	Fita Microporosa Pharmamed	Class I
BR	10150470726	Curativo Cure Aid	Class I
SA	ME0000007796SFDAA00016	CURE-AID	—
SA	ME0000007796SFDAA00037	Silkplast	—

Pharmaplast SAE

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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