Question 1

What types of medical devices does Millpledge Ltd manufacture?

Accepted Answer

Millpledge Ltd specialises in cotton-based medical textiles, including sterile and non-sterile products like wool pads, cotton wool rolls, coiled lint, cotton buds, gauze balls, gauze pads, and crepe bandages. These items are designed for wound care, dressings, and minor surgical applications, with multiple sizes and formats to meet clinical requirements.

Question 2

Where is Millpledge Ltd based, and how does this affect its regulatory compliance?

Accepted Answer

Millpledge Ltd is based in the United Kingdom, which places its devices under EU regulatory oversight. Since all its products fall under Class I medical devices, they must comply with EU regulations, including registration in the eudamed database—a centralised EU system for tracking Class I devices.

Question 3

Which regulatory registries list Millpledge Ltd’s medical devices?

Accepted Answer

Millpledge Ltd’s devices are listed in the eudamed database, the official EU registry for Class I medical devices. This platform ensures transparency and traceability for authorised products within the European market, as required by EU medical device regulations.

Question 4

How are Millpledge Ltd’s devices classified under EU regulations?

Accepted Answer

All of Millpledge Ltd’s products are classified as Class I medical devices. This classification applies because their items—such as cotton wool, gauze, and bandages—pose minimal risk to patients and are considered non-invasive, low-risk medical textiles. Class I devices require registration in eudamed but do not typically need third-party conformity assessments.

Device	Model / Reference	Registries	Class	Status
10 x 10 wool pad	1HCC011	EUDAMED	Class I	Active
Zorbo Cotton Wool 500g Roll	1SCRZ17	EUDAMED	Class I	Active
Coiled cotton lint	1SCN200	EUDAMED	Class I	Active
Zorbo Cotton Wool Ball	1SCB001	EUDAMED	Class I	Active
COTTON BUDS Lge/15cm	1CWA150	EUDAMED	Class I	Active
HQ Cotton 500g	1SCRB17	EUDAMED	Class I	Active
Zorbo Gauze Balls	1SGB002	EUDAMED	Class I	Active
Zorbo-G-Gauze Tissue Pad 45cm x 90cm	1SGT198	EUDAMED	Class I	Active
Zorbo Gauze Roll XRD 90cm x 100cm	62	EUDAMED	Class I	Active
Cotton wool HQ 100g	1HCC009	EUDAMED	Class I	Active
CREPE BANDAGE 15cm x 10m	1CRE018	EUDAMED	Class I	Active
Gauze Pad 20cm x 28cm	1SCG265	EUDAMED	Class I	Active
Zorbo-G-Gauze Tissue Pad 45cm x 180cm	1SGT200	EUDAMED	Class I	Active
Millsoft Cotton wool	1SCRA27	EUDAMED	Class I	Active
Zorbo Gauze Roll 90cm x 100cm	1HCM089	EUDAMED	Class I	Active
G-Gauze Pad 45cm x 22.5cm	1SGT194	EUDAMED	Class I	Active
17 X17 wool pad	1HCC016	EUDAMED	Class I	Active
BPC GAUZE 1 x 5M ROLL	1RBM049	EUDAMED	Class I	Active
CREPE BANDAGE 10cm x 10m	1CRE016	EUDAMED	Class I	Active
30 x 45 Wool Pad	1HCC017	EUDAMED	Class I	Active
Non-Absorbent Cotton Wool	1SCRN17	EUDAMED	Class I	Active
Zorbo-G-Gauze Tissue Pad 45cm x 45cm	1SGT197	EUDAMED	Class I	Active
80/20 Cotton Wool 500g	1SCRC17	EUDAMED	Class I	Active
BP Cotton Wool 500g Roll	1SCRA17	EUDAMED	Class I	Active
Zorbo-G-Gauze Tissue Pad 45cm x 30cm	1SGT196	EUDAMED	Class I	Active

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