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
Medical/Laboratory Sieves with chain Ø 75	CIL032004001	EUDAMED	Class I	Active
Wire Mesh Basket 255 x 245 x 70	CIL001003004	EUDAMED	Class I	Active
Instrument Trays without Lid 250 x 140 x 50	CIL040004001	EUDAMED	Class I	Active
Medical/Laboratory Sieves with handle Ø 45	CIL032002002	EUDAMED	Class I	Active
Scaler Trays 225 x 100	CIL058005001	EUDAMED	Class I	Active
Flat Base Baskets 480 x 480 x 100	CIL002009005	EUDAMED	Class I	Active
Kidney Tray with lid 280	CIL043008002	EUDAMED	Class I	Active
Endoscope Baskets (for two endoscopes) 460 x 80 x 52	CIL011004002	EUDAMED	Class I	Active
Flat Base Baskets 480 x 360 x 50	CIL002008002	EUDAMED	Class I	Active
Sterile Goods Baskets 600 x 400 x 300 Standard	CIL005003002	EUDAMED	Class I	Active
Catheter Tray 350 x 90 x 45	CIL042004001	EUDAMED	Class I	Active
Instrument Trays without Lid 350 x 250 x 50	CIL040008001	EUDAMED	Class I	Active
Medical/Laboratory Sieves with chain Ø 55	CIL032003001	EUDAMED	Class I	Active
Perforated Stainless Steel Micro Basket 160 x 40 x 20	CIL012008001	EUDAMED	Class I	Active
Bur Holder & Stand 75 x 20 x 60 (Plug in 6 Holes)	CIL029001003	EUDAMED	Class I	Active
Bed Pan Chamber	CIL051004001	EUDAMED	Class I	Active
Basket SPRI (Single Frame) 600 x 300 x 100	CIL006006002	EUDAMED	Class I	Active
Instrument Boxes 150 x 80 x 40	CIL041001001	EUDAMED	Class I	Active
Basket SPRI (Double frame with folding handle) 585 x 395 x 195	CIL006001002	EUDAMED	Class I	Active
Wire Net Baskets 250 x 170 x 70	CIL009001001	EUDAMED	Class I	Active
Basket SPRI (Double Frame) 600 x 400 x 150	CIL006004003	EUDAMED	Class I	Active
Wire Mesh Basket 480 x 360 x 100	CIL001008005	EUDAMED	Class I	Active
Sterile Goods Baskets 600 x 300 x 300 Front Access	CIL005002004	EUDAMED	Class I	Active
Surgical Needle Case 150 x 90 x 15	CIL021001001	EUDAMED	Class I	Active
Dressing Drums 80 x 80	CIL044001001	EUDAMED	Class I	Active
Implantology Cassettes 100 x 90 x 50	CIL024003001	EUDAMED	Class I	Active
Flat Base Baskets 120 x 250 x 60	CIL002001003	EUDAMED	Class I	Active
Basket SPRI (Single Frame) 600 x 300 x 200	CIL006006006	EUDAMED	Class I	Active
Instrument Trays with Lid 400 x 300 x 50	CIL040010501	EUDAMED	Class I	Active
Stainless Steel Inlay for Flat Base Basket 431 x 258 x 45	CIL015002002	EUDAMED	Class I	Active
Instrument Trays with Lid 300 x 250 x 50	CIL040007501	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 90 x 90 x 50	CIL004005001	EUDAMED	Class I	Active
Lid Wire Mesh Baskets 255 x 245	CIL001003501	EUDAMED	Class I	Active
Wire Mesh Basket 485 x 255 x 60	CIL001007003	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 220 x 140 x 50	CIL004011001	EUDAMED	Class I	Active
Fine Mesh Basket with locking clip 275 x 200 x 35	CIL004016001	EUDAMED	Class I	Active
Flat Base Baskets 480 x 480 x 30	CIL002009001	EUDAMED	Class I	Active
Micro Cassette 74 x 45 x 20	CIL023002001	EUDAMED	Class I	Active
Stainless Steel Inlays for Flat Base Basket 226 x 258 x 45	CIL015001002	EUDAMED	Class I	Active
Kidney Tray without Lid 180	CIL043005001	EUDAMED	Class I	Active
Bed Pan (Child) Perfection	CIL051001002	EUDAMED	Class I	Active
Surgical Needle Case Round 65 x 15	CIL021003001	EUDAMED	Class I	Active
Instrument Trays without Lid 300 x 250 x 50	CIL040007001	EUDAMED	Class I	Active
Sterile Goods Baskets 600 x 400 x 150 Standard	CIL005003001	EUDAMED	Class I	Active
Instrument Boxes 180 x 80 x 40	CIL041003001	EUDAMED	Class I	Active
Lid Wire Net Baskets 450 x 340	CIL009003501	EUDAMED	Class I	Active
Flat Base Baskets 480 x 360 x 30	CIL002008001	EUDAMED	Class I	Active
Basket SPRI (Double frame with folding handle) 600 x 300 x 150	CIL006002003	EUDAMED	Class I	Active
Fixing Clamps (to be fix in half din) 230 x 220 x 39	CIL016004001	EUDAMED	Class I	Active
Endodontic Cassettes 32 Holes 65 x 43 x 82	CIL025003001	EUDAMED	Class I	Active

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