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ENVASTE LTD

Mauritius·MU-MF-000030801

Last updated September 18, 2026

About

Leading medical device manufacturer specializing in the design, manufacture, and global distribution of high-performance urology and endoscopy instruments.

From the manufacturer's own website. Source

What ENVASTE LTD makes

Envaste Ltd manufactures balloon dilators and access sheaths for urological and nephrological procedures. The portfolio includes ureteral and nephrostomy balloon dilators in varying calibers, designed for controlled dilation of urinary tract obstructions. Access sheaths are also provided for use in ureteroscopy and related interventions.

These devices are classified as Class IIa under EU regulations and are listed in the EUDAMED database. The company operates from Mauritius and adheres to EU regulatory requirements for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Mauritius
Address: 4th Floor, Maeva Tower Building, , Ebene, Mauritius
Website: www.envaste.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +230 4632084
PRRC Contact: Amit Pradip Bhangale
EUDAMED SRN: MU-MF-000030801
FDA FEI Number: —
DUNS Number: —

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
Tahina 0.038" Nephrostomy Balloon Dilator	UDB-0308120S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0109545S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0210855S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0105040LPS	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0112035S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0211055S	EUDAMED	Class IIa	Active
Tahina 0.038" Nephrostomy Balloon Dilator	UDB-0310120S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0220855S	EUDAMED	Class IIa	Active
Tahina 0.018" Ureteroscopy Balloon Dilator	UDB-0204040S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0106040LPS	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0106060S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0104060S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0105060S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0121055S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0121555S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0109520S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0112020S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0121255S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0109535S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0221855S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0104040S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0112045S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0211855S	EUDAMED	Class IIa	Active
Tahina 0.018" Ureteroscopy Balloon Dilator	UDB-0205040S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0105040S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0111055S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0104100S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0106100S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0221055S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0110728S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0110735S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0111555S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0121855S	EUDAMED	Class IIa	Active
Manawa Access Sheath	UAS-0114045S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0120655S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0106040S	EUDAMED	Class IIa	Active
Tahina 0.038" Ureteral Balloon Dilator	UDB-0105100S	EUDAMED	Class IIa	Active
Amara Balloon Dilator	GDB-0111855S	EUDAMED	Class IIa	Active

Related Companies

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