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
Basket SPRI (Single Frame) 600 x 300 x 180	CIL006006005	EUDAMED	Class I	Active
Wire Mesh Basket 405 x 255 x 30	CIL001005001	EUDAMED	Class I	Active
Trinket Box (Lid Wire Mesh) 90 x 60 x 25	CIL020001002	EUDAMED	Class I	Active
Bur Holder & Stand 75 x 20 x 50 (Plug in 6 Holes)	CIL029001002	EUDAMED	Class I	Active
Dressing Drums 290 x 240	CIL044009001	EUDAMED	Class I	Active
Medical/Laboratory Sieves with handle Ø 55	CIL032003002	EUDAMED	Class I	Active
Basket Racks 600 x 400 x 44	CIL039003001	EUDAMED	Class I	Active
Flat Base Baskets 480 x 250 x 30	CIL002006001	EUDAMED	Class I	Active
Micro Ophthalmic Baskets 240 x 250 x 40	CIL008001001	EUDAMED	Class I	Active
Edinburgh Trays Aluminium sheet trays 610 x 305 x 38	CIL019002001	EUDAMED	Class I	Active
Dressing Drums 130 x 290	CIL044003001	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 190 x 85 x 100	CIL004009001	EUDAMED	Class I	Active
Trinket Box (Lid Perforated) 205 x 105 x 35	CIL020005001	EUDAMED	Class I	Active
Medical/Laboratory Sieves 200	CIL031002200	EUDAMED	Class I	Active
Instrument Trays with Lid 350 x 250 x 50	CIL040008501	EUDAMED	Class I	Active
Endodontic Cassettes 16 Holes 35 x 39 x 50	CIL025001001	EUDAMED	Class I	Active
Iodine Cup 10	CIL013006005	EUDAMED	Class I	Active
Flat Base Baskets 485 x 255 x 100	CIL002007005	EUDAMED	Class I	Active
Kidney Tray (Shallow Type) 170	CIL043001001	EUDAMED	Class I	Active
Forceps Jar 200 x 65	CIL046004001	EUDAMED	Class I	Active
Instrument Boxes 300 x 140 x 60	CIL041007001	EUDAMED	Class I	Active
Endoscope Baskets 460 x 225 x 52	CIL011012002	EUDAMED	Class I	Active
Wire Mesh Basket 515 x 245 x 50	CIL001010002	EUDAMED	Class I	Active
Wire Racks (with Round Ends ) 600 x 400 x 15	CIL039004001	EUDAMED	Class I	Active
Wire Mesh Basket 240 x 250 x 60	CIL001002003	EUDAMED	Class I	Active
Flat Base Baskets 540 x 250 x 70	CIL002011004	EUDAMED	Class I	Active
Iodine Cup 2	CIL013006001	EUDAMED	Class I	Active
Wire Mesh Basket 480 x 480 x 100	CIL001009005	EUDAMED	Class I	Active
Wire Mesh Basket 540 x 250 x 30	CIL001011001	EUDAMED	Class I	Active
Flat Base Baskets 540 x 250 x 50	CIL002011002	EUDAMED	Class I	Active
Lid Flat Base Baskets 540 x 250	CIL002011501	EUDAMED	Class I	Active
Dressing Drums 390 x 290	CIL044012001	EUDAMED	Class I	Active
Wash Basin 350	CIL013001002	EUDAMED	Class I	Active
Endoscope Baskets (for one endoscope) 290 x 80 x 52	CIL011002001	EUDAMED	Class I	Active
Wire Mesh Basket 120 x 250 x 60	CIL001001003	EUDAMED	Class I	Active
Dressing Drums 120 x 120	CIL044002001	EUDAMED	Class I	Active
Endoscope Baskets 310 x 150 x 77	CIL011011001	EUDAMED	Class I	Active
Basket SPRI (Single Frame) 600 x 400 x 100	CIL006005001	EUDAMED	Class I	Active
Kidney Tray without Lid 280	CIL043008001	EUDAMED	Class I	Active
Wire Mesh Basket 405 x 250 x 30	CIL001004001	EUDAMED	Class I	Active
Instrument Trays without Lid 400 x 300 x 50	CIL040010001	EUDAMED	Class I	Active
Wire Mesh Basket 240 x 250 x 100	CIL001002005	EUDAMED	Class I	Active
Bed Pan (Adult) Perfection	CIL051001001	EUDAMED	Class I	Active
Basket Racks 600 x 400 x 15	CIL039001001	EUDAMED	Class I	Active
Kidney Tray without Lid 150	CIL043004001	EUDAMED	Class I	Active
Wire Mesh Basket 120 x 250 x 70	CIL001001004	EUDAMED	Class I	Active
Sterile Goods Baskets 575 x 280 x 265 Standard	CIL005001002	EUDAMED	Class I	Active
Flat Base Baskets 480 x 360 x 70	CIL002008004	EUDAMED	Class I	Active
Dental Instrument Cassettes 280 x 183 x 32	CIL022009001	EUDAMED	Class I	Active
Endoscope Baskets 670 x 80 x 52	CIL011006001	EUDAMED	Class I	Active

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