Question 1

What types of medical devices does Chaplet International Pvt Ltd manufacture?

Accepted Answer

Chaplet International Pvt Ltd specializes in two main categories: reusable instrument trays and single-use endoscopic spray catheters. Their reusable products include surgical accessories like micro forceps, test tube stands, dressing drums, wire mesh baskets, and various mesh cassettes and baskets with lids. These items are designed for repeated use in clinical settings, ensuring durability and sterility between procedures.

Question 2

Where is Chaplet International Pvt Ltd based, and how does that affect its regulatory standing?

Accepted Answer

Chaplet International Pvt Ltd is based in Pakistan. While the company’s location determines its primary regulatory jurisdiction (e.g., compliance with Pakistani medical device regulations), its devices are also registered in the EU’s eudamed database, indicating they meet EU requirements for Class I devices. Registration in eudamed does not imply EU approval but confirms compliance with EU regulatory processes for market placement in the EU.

Question 3

Which regulatory registries list Chaplet International Pvt Ltd’s devices, and why is this important?

Accepted Answer

Chaplet International Pvt Ltd’s devices are listed in the eudamed database, the EU’s official registry for medical devices. This registry is critical because it provides transparency on devices authorized for sale within the European Economic Area (EEA). Listing in eudamed ensures traceability and compliance with EU regulations, helping healthcare providers and authorities verify the device’s classification (Class I) and regulatory status before use.

Question 4

How are Chaplet International Pvt Ltd’s devices classified, and what does that classification mean for their use?

Accepted Answer

Chaplet International Pvt Ltd’s devices are classified as Class I medical devices. This classification applies to products posing minimal risk to patients and users, such as reusable surgical accessories and single-use endoscopic catheters. Class I devices typically require less stringent regulatory oversight compared to higher-risk classes, but they still must comply with essential safety and performance requirements to ensure safe and effective use in clinical environments.

Device	Model / Reference	Registries	Class	Status
Bipolar Forcep Basket 480 x 250 x 38	CIL010003001	EUDAMED	Class I	Active
Basket SPRI (Double Frame) 600 x 400 x 100	CIL006004001	EUDAMED	Class I	Active
Lid Wire Net Baskets 250 x 170	CIL009001501	EUDAMED	Class I	Active
Edinburgh Trays Aluminium sheet trays 305 x 305 x 51	CIL019003001	EUDAMED	Class I	Active
Flat Base Baskets 480 x 250 x 50	CIL002006002	EUDAMED	Class I	Active
Basket SPRI (Single Frame) 600 x 300 x 150	CIL006006004	EUDAMED	Class I	Active
Cotton Dispenser Standard	CIL059001001	EUDAMED	Class I	Active
Measuring Jug 500	CIL053002001	EUDAMED	Class I	Active
Medical/Laboratory Sieves 140	CIL031001140	EUDAMED	Class I	Active
Instrument Trays without Lid 200 x 100 x 25	CIL040001001	EUDAMED	Class I	Active
Wire Mesh Basket 255 x 245 x 50	CIL001003002	EUDAMED	Class I	Active
Wire Mesh Basket 480 x 250 x 70	CIL001006004	EUDAMED	Class I	Active
Wire Mesh Basket 485 x 255 x 70	CIL001007004	EUDAMED	Class I	Active
Lid Flat Base Baskets 120 x 250	CIL002001501	EUDAMED	Class I	Active
Instrument Boxes 200 x 100 x 40	CIL041004001	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 105 x 70 x 25	CIL004007001	EUDAMED	Class I	Active
Ultra Fine Mesh Baskets 230 x 100 x 60	CIL034005001	EUDAMED	Class I	Active
Measuring Jug 250	CIL053001001	EUDAMED	Class I	Active
Wire Mesh Basket 515 x 245 x 60	CIL001010003	EUDAMED	Class I	Active
Medical/Laboratory Sieves with handle Ø 40	CIL032001002	EUDAMED	Class I	Active
Gallipots 12	CIL013004006	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 100 x 100 x 50	CIL004006001	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 235 x 155 x 40	CIL004012001	EUDAMED	Class I	Active
Instrument Trays without Lid 250 x 200 x 50	CIL040005001	EUDAMED	Class I	Active
Iodine Cup 6	CIL013006003	EUDAMED	Class I	Active
Dressing Jar 120 x 120	CIL045005001	EUDAMED	Class I	Active
Trinket Box lid Wire Mesh 205 x 105 x 35	CIL020005002	EUDAMED	Class I	Active
Instrument Trays without Lid 200 x 150 x 40	CIL040002001	EUDAMED	Class I	Active
Gallipots 8	CIL013004004	EUDAMED	Class I	Active
Medical/Laboratory Sieves with chain Ø 65	CIL032005001	EUDAMED	Class I	Active
Instrument Boxes 250 x 125 x 50	CIL041006001	EUDAMED	Class I	Active
Fine Mesh Box with catch locks 275 x 200 x 40	CIL003003001	EUDAMED	Class I	Active
Wire Mesh Basket 405 x 255 x 100	CIL001005005	EUDAMED	Class I	Active
Flat Base Baskets 485 x 255 x 60	CIL002007003	EUDAMED	Class I	Active
Perforated Sheet Trays 480 x 480 x 50	CIL018005001	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 80 x 40 x 30	CIL004003002	EUDAMED	Class I	Active
Flat Base Baskets 120 x 250 x 50	CIL002001002	EUDAMED	Class I	Active
Lid Wire Mesh Baskets 120 x 250	CIL001001501	EUDAMED	Class I	Active
Ultra Fine Mesh Baskets 80 x 80 x 34	CIL034002001	EUDAMED	Class I	Active
Wire Mesh Basket 485 x 255 x 100	CIL001007005	EUDAMED	Class I	Active
Dental Instrument Cassettes 205 x 100 x 30	CIL022012001	EUDAMED	Class I	Active
Sterile Goods Baskets 600 x 300 x 300 Standard	CIL005002003	EUDAMED	Class I	Active
Flat Base Baskets 480 x 480 x 50	CIL002009002	EUDAMED	Class I	Active
Kidney Tray (Shallow Type) 240	CIL043003001	EUDAMED	Class I	Active
Wire Net Baskets 450 x 340 x 70	CIL009003001	EUDAMED	Class I	Active
Wire Mesh Basket 405 x 250 x 70	CIL001004004	EUDAMED	Class I	Active
Dental Instrument Cassettes 205 x 125 x 30	CIL022013001	EUDAMED	Class I	Active
Trinket Box lid Wire Mesh 150 x 100 x 25	CIL020004002	EUDAMED	Class I	Active
Flat Base Baskets 480 x 250 x 100	CIL002006005	EUDAMED	Class I	Active
Perforated Stainless Steel Micro Basket 100 x 100 x 50	CIL012005001	EUDAMED	Class I	Active

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